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Intra-arterial lidocaine administration during uterine fibroid embolization to reduce the immediate postoperative pain: a prospective randomized study

Intra-arterial lidocaine administration during uterine fibroid embolization to reduce the... Background: To investigate if intra-arterial lidocaine administrated immediately after the embolisation endpoint reduces the pain. Methods: Forty patients were randomised and 36 completed the study for purposes of analysis. In one group, the patients got 1% 10 ml lidocaine (100 mg) administered into each uterine artery immediately after embolisation with microspheres. The other group was embolised without supplementary lidocaine. The patients scored their pain on a visual analogue scale (VAS) 2 h, 4 h, 7 h, 10 h and 24 h after embolisation, and the total amount of used morphine was noted. Three-month follow-up MRI control was scheduled for all the patients to investigate the infarction rate. Results: Embolisation was performed without any complications and with embolisation of both uterine arteries in all cases. Intra-arterial lidocaine was administered in all 20 patients without complications, and 20 patients in a control group did not receive lidocaine intra-arterial. VAS schemes showed a significant reduction in pain experience 2 h after UFE where mean pain score in the lidocaine group was 42.7 ± 21.4 compared with the control group in which the mean pain score was 61.1 ± 20.4 (p < 0.02). There was no significant difference in pain score 4 h, 7 h, 10 h and 24 h after UFE. In the lidocaine group, the mean amount of used morphine was significantly less with 11.2 mg compared with 20.2 mg in the control group (p < 0.03). Three months of MR follow-up control showed no significant difference in the grade of fibroid infarction. Conclusion: Intra-arterial Lidocaine administration after embolisation is safe and effective in reducing post- procedural pain in the early hours and opioid usage in the first 24 h following UAE. Keywords: Uterine fibroid embolisation, Intraarterial lidocaine, Pain after embolisation, Post-embolization syndrome Introduction UFE is a well known adverse effect of the treatment and Uterine fibroid embolisation (UFE) is a well-described is the most frequent patient complaint (Spencer et al. and well-established interventional radiology procedure 2013). The pain is believed to occur due to temporary to treat symptomatic uterine fibroids. The efficacy and myometrium ischemia after embolisation. The pain usu- long term outcome is documented in several randomised ally starts 1 hour after UFE and increases during the fol- studies and long-term follow-up results are confirmed lowing 5–7 h (Spencer et al. 2013). After that period, the (Hehenkamp et al. 2008; Scheurig-Muenkler et al. 2013; pain usually decreases and the majority of patients are The REST Investigators. 2007). Pain immediately after discharged within 24 h after UFE without pain. Few studies are describing that intra-arterial lidocaine can re- duce the pain during embolisations including UFE * Correspondence: duvnjak.stevo@gmail.com (Noel-Lamy et al. 2017; Keyoung et al. 2001; Lee et al. Department of Radiology, Odense University Hospital, Sdr. Boulevard 29, 2001). Another more invasive analgesic technique to re- 5000 Odense, DK, Denmark Institute for Clinical Research, University of Southern Denmark, Odense, duce or eliminate embolization-induced ischemic pain is Denmark © The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Duvnjak and Andersen CVIR Endovascular (2020) 3:10 Page 2 of 5 hypogastric nerve blockade which has shown promising heart block and active pelvic infection were exclusion results (Binkert et al. 2015; Yoon et al. 2018). criteria. After embolisation, the patients were transferred The present study aims to investigate if intra-arterial to the ward and a visual analogue pain scale (VAS) with lidocaine administrated in the uterine arteries immedi- oral and written instructions was given to the patients ately after UFE reduces the pain. (Bijur et al. 2001). The patients marked their sensation of pain on the VAS at 2 h, 4 h, 7 h, 10 h and 24 h after embol- Materials and methods isation. VAS schemes were collected the following day be- Institutional board and ethical committee approval were fore discharge and the total amount of used morphine was obtained (S-345678). Between August 2017 and July registered as well. Three-month follow-up MRI control 2019, all patients with symptomatic uterine fibroids who follow-up was scheduled for all the patients to investigate accepted participation were block randomised were the infarction rate percentage using the description de- smaller blocks of fewer patients randomised to the two fined as fibroma infarction of 100%, 90–99%, or below treatments at a time intending to have 20 patients in 90% (Duvnjak et al. 2017). Infraction, less than 90% of each group. The patients in one group had 1% 10 ml total fibroid burden, was defined as insufficient. lidocaine (100 mg) administrated intra-arterially immedi- Descriptive statistics were used for baseline patients ately after embolisation in each uterine artery, so the and fibroid characteristics and were presented as num- total doses given to each patient was 200 mg of lido- ber and percentage and as mean and standard deviation caine. In the other (control) group of patients, the pro- (SD). The student’s t-test was used for comparison be- cedure was performed according to standard principles tween the groups regarding the used amount of mor- without supplementary injection of lidocaine. The pa- phine and pain experience. P-value < 0.05 was tient’s age and symptoms, fibroid number, localisation considered statistically significant. SPSS software pack- and total uterine and dominant fibroid volume changes age (Statistics 21, IBM Corporation, Armonk, NY, USA) before and after an embolization were analysed. program was used for analysis. The standard embolisation technique was performed in local anaesthesia via either transfemoral or transradial Results access using diagnostic 5F catheter advanced into the in- Fifty-four consecutive patients were treated with embol- ternal iliac artery. Further, in all cases, micro-catheter isation in the period August 2017 –July 2019 at the De- (Direxion hi-flow 0.027- in., Boston scientific Massachu- partment of Radiology. Fourteen patients did not want setts MA, USA) was used and advanced into the hori- to participate in the study and were excluded. There zontal part of the uterine arteries. Embolisation with were no patients with allergy to lidocaine or morphine microspheres tris-acryl gelatin (500–900 μm) (Embo- or with heart problems. Thus, in all 40 patients were in- sphere, Biosphere Medical, Paris, France) to near stasis cluded in the study and all gave written consent. In all defined as slow forward flow trough the main uterine ar- patients, UFE was performed without complications and tery with at least five heartbeats for clearance of contrast with embolisation of both uterine arteries as intended. from uterine artery with the pruning of peripheral ves- The demography of the patients, baseline fibroid de- sels. The total amount of the used microspheres was re- scription and patient symptoms are presented in Table 1. corded and compared between the groups. All patients There was no statistically significant difference between had patient-controlled analgesia pump (PCA) loaded the lidocaine treated group and the control group in with 2 mg morphine sulphate and an intermittent dose terms of age (p < 0.78), fibroid numbers (p < 0.89), fi- of 1 mg morphine with lockout intervals of 10 min. Be- broid location (p < 0.22), dominant symptoms (p < 0.54), fore the beginning of the embolisation, a loading dose of or amount of used microspheres p < (0.19). Intra-arterial 2 mg morphine was given to all patients. The patients lidocaine was administrated in all 20 patients without were instructed to push the button of the PCA for the complications and was well tolerated. VAS schemes first time before the pain developed. No antibiotics were showed a significant difference in pain experienced be- given and no urinary catheter was deployed. There was tween the groups 2 h after UFE. The median pain experi- no standardised regimen concerning usage of adjunctive enced in the lidocaine group was 45 ± 21.1 compared analgesia and sedation, and if needed, some patients take with the control group 60.1 ± 15.2 (p < 0.02) (Fig. 1). In additional drugs such as non-steroid anti-inflammatory the control group, four patients were not included in the medications on the ward individually. analysis due to either withdrawal from the study (two Inclusion criteria were symptomatic fibroids in a pre- patients) or due to not properly filled-in VAS schemes menopausal woman with bleeding and/or bulky symp- (two patients). There was no difference in pain experi- toms. Size and number of fibroids were not exclusion ence, 4 h, 7 h, 10 h, and 24 h after UFE p < 0.06, p < 0.83, criteria. Patients who did not want to participate in the p < 0.61, p < 0.15). The total amount of used morphine study were excluded. Allergy to morphine or lidocaine, was recorded 24 h after UFE. In the lidocaine group, the Duvnjak and Andersen CVIR Endovascular (2020) 3:10 Page 3 of 5 Table 1 Pre-embolization patients and fibroid characteristics Lidocaine group Control group p-value Mean age (years-SD) 44.4 ± 3.3 43.1 ± 5.11 p < 0.78 3 3 Dominant fibroid volume (mean-SD) 183.1 ± 206.5 cm 262.8 ± 188.7 cm p < 0.26 Singular fibroid n = 9 (45%) n = 7 (44%) 2–5 fibroids n = 4 (20%) n = 6 (37%) > 5 fibroids n = 7 (35%) n = 3 (19%) Dominant symptom p < 0.54 Bleeding symptoms n = 11 (55%) n = 6 (37%) Bulk symptoms n = 5 (25%) n = 7 (44%) Both bleedings and bulk symptoms n = 4 (20%) n = 3 (19%) mean amount of used morphine was 11.2 mg compared significant difference in terms of fibroid infarction with 20.2 mg in the control group (p < 0.03). The de- between the groups (Table 3). tailed scores of the pain experience and comparison be- tween the groups and the use of morphine are presented Discussion in Table 2. All patients were discharged about 24 h after The present randomised study confirmed that intra- UFE and continued on non-steroid anti-inflammatory arterial lidocaine administration after UFE reduce the medication. Three patients (two in the lidocaine group pain in the first hours after embolisation. Lidocaine has and one in the control group) phoned back due to pain a half-life about 90–120 min, and the effect was con- experienced on day three after UFE, but there were no firmed in this study during the first 2 hours after UFE. re-admissions to hospital after discharge. No complica- Noel-Lamy et al. 2017, showed in prospective study tions or readmissions occurred during 3 months of similar results with the maximal effect and pain control follow-up in any group. Three-month follow-up MRI in within two to 4 hours after UFE. In another study, control was obtained in 36 patients and showed no pain control was achieved in a longer period after UFE Fig. 1 Boxplot showing the significant difference in a median pain Duvnjak and Andersen CVIR Endovascular (2020) 3:10 Page 4 of 5 Table 2 The pain experience and used of morphine -comparison between the groups Lidocaine group Control group p-value Pain experience 2 h after UFE (mean-SD) 42.7 ± 21.4 61.1 ± 20.4 p < 0.02 Pain experience 4 h after UFE (mean-SD) 39.7 ± 23.1 53.7 ± 21 p < 0.06 Pain experience 7 h after UFE (mean-SD) 41.5 ± 20.8 42.8 ± 15.4 p < 0.83 Pain experience 10 h after UFE (mean-SD) 34.7 ± 19.6 31.8 ± 12.5 p < 0.61 Pain experience 24 h after UFE (mean-SD) 20.7 ± 14.5 27.3 ± 12.5 p < 0.15 Total amount of used morphine mean value (mg-SD) 11.2 ± 7.3 (range: 4–32) 20.2 ± 10.8 (range:10–44) p < 0.03 but the methodology was not the same as in the present investigation demonstrates that this technique works, study (Kim et al. 2008). Katsumori et al. 2020, in his but this is a subjective opinion. In this study embolisa- study, did not achieve significant statistical difference tion endpoint was sluggish forward flow and we admin- comparing the patients who received intra-arterial lido- istrated lidocaine over 30–60 s very slowly. Control MR caine and those who did not get the lidocaine. This imaging showed similar results compared with a control study was retrospective including the patients treated group allowing us to conclude that this technique is effi- with embolisation from 2014 to 2019. The amount of cient. The administration of lidocaine before or together used lidocaine was 80 mg comparing to our study, where with microspheres might reduce the fibroid infarction 200 mg lidocaine was used that can probably explain the rate and thus not end-up with an optimal result and different outcome. Zhan et al. 2005, used in his study 40 therefore is not recommended (Noel-Lamy et al. 2017; mg od lidocaine and showed significant pain reduction Keyoung et al. 2001). All patients had a PCA pump despite the small amount of the drug in the patients allowing us to record the total amount of morphine who received lidocaine but the used microparticles and which is an advantage compared with another similar time to record pain was different than in our study. study (Noel-Lamy et al. 2017). Hypogastric nerve block- Further, Katsumori et al. 2020 recorded the VAS pain ade is invasive and according to the literature not com- during the embolisation and first, 3 hours after the inter- plicated to learn (Binkert et al. 2015). However, vention. The maximal effect of intra-arterial lidocaine is intraarterial lidocaine administration is a simpler less- in the first 2 hours due to the half-life of the drug. invasive technique than hypogastric nerve blockade with The pain experienced in our study was lower com- a likely lesser learning curve and could be widely pared with the control group after 4 h,7 h,10 h, and 24 h adopted more easily. Therefore, very simple intraarterial but without statistical significance, similar to Katsumori lidocaine administration in total doses of 200 mg is pref- et al. 2020 study confirming that lidocaine has the max- erable in our opinion despite the limited long-term pain imal effect in the first 2 hours. effect due to lidocaine metabolism. A recent published The intra-arterial lidocaine administration was safe in systemic review emphasises the need for more evidence, all patients without any complaints and adverse events and no clear advantage of any of the used methods for and was easy and safe to deliver after the embolisation pain control after UFE have been demonstrated so far endpoint was achieved. In previously published studies, (Saibudeen et al. 2019). there were no reported cases of adverse reactions during The limitation of this study are small number of the the intraarterial lidocaine administration as well (Noel- patients, not double-blinded design and drop-out of four Lamy et al. 2017; Keyoung et al. 2001; Lee et al. 2001). patients that withdrew or did not fill in the VAS schema When the embolisation endpoint is achieved, injection properly. Further, different access via transfemoral or of lidocaine might theoretically reflux backwards into transradial access could be a possible confounding factor other vessels, but it seems not to be the case as present due to early mobilisation after transradial access and Table 3 Detail about used microspheres and MR three months control results Lidocaine group Control group p-value The total amount of used microspheres (ml- SD) 6.9 ± 2.5 9.7 ± 2.8 p < 0.19 3 3 Dominant fibroid volume reduction (three months control) 84.4 ± 92 cm 145.1 ± 175 cm p < 0.15 3 3 Total uterine volume 161,7 ± 154 cm 261,9 ± 288 cm P < 0.26 Total fibroid burden infarction p < 0.86 100% or 90–99%-fibroid infraction 18 (94%) 14 (95%) < 90% fibroid infarction 2 (6%) 2 (5%) Duvnjak and Andersen CVIR Endovascular (2020) 3:10 Page 5 of 5 eventualy use of additional non-steroid anti-inflammatory with Trisacryl gelatin microspheres for leiomyoma. J Vasc Interv Radiol 31: 114–120 drugs in the immediately post-embolisation period. Finally, Keyoung JA, Levy EB, Roth AR, Gomez-Jorge J, Chang TC, Spies JB (2001) the specific size and volume of used embosphere was not Intraarterial lidocaine for pain control after uterine artery embolization for standardised or analysed systematically. leiomyomata. J Vasc Interv Radiol 12:1065–1069 Kim HS, Czuczman GJ, Nicholson WK, Pham LD, Richman JM (2008) Pain levels within 24 hours after UFE:a comparison of morphine and fentanyl patient- Conclusion controlled analgesia. Cardiovasc Intervent Radiol 31:1100–1107 Intra-arterial Lidocaine administration after embolisation Lee SH, Hahn ST, Park SH (2001) Intraarterial lidocaine administration for relief of pain resulting from transarterial chemoembolization of hepatocellular is safe and effective in reducing post-procedural pain in carcinoma: its effectiveness and optimal timing of administration. Cardiovasc the early hours and opioid usage in the first 24 h follow- Intervent Radiol 24:368–371 ing UAE. Further studies of how further to reduce pain Noel-Lamy M, Tan KT, Simons ME, Sniderman KW, Mironov O, Rajan DK (2017) Intraarterial Lidocaine for Pain Control in Uterine Artery Embolization: A are warranted. Prospective, Randomized Study. J Vasc Interv Radiol 28:16–22 Saibudeen A, Makris GC, Elzein A et al (2019) Pain management protocol during Abbreviations uterine fibroid embolization: a systematic review of the evidence. Cardiovasc F: French; MR: Magnentic resonance; PCA: Patient-controlled analgesia pump; Intervent Radiol. https://doi.org/10.1007/s00270-019-02327-1 [Epub ahead of UFE: Uterine fibroid embolization; VAS: Visual analogue scale print] Scheurig-Muenkler C, Koesters C, Powerski MJ, Grieser C, Froeling V, Kroencke TJ Acknowledgments (2013) Clinical long-term outcome after uterine artery embolization: Not applicable. sustained symptom control and improvement of quality of life. J Vasc Interv Radiol 24(6):765–771 Authors’ contributions Spencer EB, Stratil P, Mizones H (2013) Clinical and periprocedural pain SD performed the procedures, collect the data and perform, analysis, and management for uterine fibroid embolization. Semin Interv Radiol 30:354–363 manuscript preparation. PEA assisted with data analysis and manuscript The REST Investigators (2007) Uterine-artery embolization versus surgery for preparation. Both authors read and approved the final manuscript. symptomatic uterine fibroids. NEJM 356:360–370 Yoon J, Valenti D, Muchantef K et al (2018) Superior Hypogastric Nerve Block as Funding Post-Uterine Artery Embolization Analgesia: A Randomized and Double-Blind This study was not supported by any funding. Clinical Trial. Radiology 289:248–254 Zhan S, Li Y, Wang G, Han H, Yang Z (2005) Effectiveness of intra-arterial Availability of data and materials anesthesia for uterine fibroid embolization using dilute lidocaine. Eur Radiol The datasets analyzed during the current study are available from the 15:1752–1756 corresponding author on reasonable request. Ethics approval and consent to participate Publisher’sNote All procedures performed in studies involving human participants were in Springer Nature remains neutral with regard to jurisdictional claims in accordance with the ethical standards of the institutional and/or national published maps and institutional affiliations. research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This project was reviewed by the NYU Winthrop Hospital Institutional Review Board and given approval. Informed consent was obtained from all patients in the study. Consent for publication Consent for publication was obtained for every individual person’s data included in the study. Informed consent was obtained from all patients in the study. Competing interests Stevo Duvnjak (SD) declares following COI- Advisory Board Boston Scientific and paid lectures –Medtronic. Poul Erik Andersen (PEA) declare that they have no conflict of interest. Received: 20 November 2019 Accepted: 13 January 2020 References Bijur PE, Silver W, Gallagher EJ (2001) Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med 8:1153–1157 Binkert CA, Hirzel FC, Gutzeit A, Zollikofer CL, Hess T (2015) Superior Hypogastric Nerve Block to Reduce Pain After Uterine Artery Embolization: Advanced Technique and Comparison to Epidural Anesthesia. Cardiovasc Intervent Radiol 38:1157–1161 Duvnjak S, Ravn P, Green A, Andersen PE (2017) Uterine fibroid embolization with acrylamido polyvinyl microspheres: prospective 12-month clinical and MRI follow-up study. Acta Radiol 58:952–958 Hehenkamp WJ, Volkers NA, Birnie E, Reekers JA, Ankum WM (2008) Symptomatic uterine fibroids: treatment with uterine artery embolization or hysterectomy—results from the randomized clinical embolisation versus hysterectomy (EMMY) trial. Radiology 246:823–832 Katsumori T, Miura H, Yoshikawa T, Seri S, Kotera Y, Asato A (2020) Intra-arterial Lidocaine Administration for Anesthesia after uterine artery embolization http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png CVIR Endovascular Springer Journals

Intra-arterial lidocaine administration during uterine fibroid embolization to reduce the immediate postoperative pain: a prospective randomized study

CVIR Endovascular , Volume 3 (1) – Feb 10, 2020

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Abstract

Background: To investigate if intra-arterial lidocaine administrated immediately after the embolisation endpoint reduces the pain. Methods: Forty patients were randomised and 36 completed the study for purposes of analysis. In one group, the patients got 1% 10 ml lidocaine (100 mg) administered into each uterine artery immediately after embolisation with microspheres. The other group was embolised without supplementary lidocaine. The patients scored their pain on a visual analogue scale (VAS) 2 h, 4 h, 7 h, 10 h and 24 h after embolisation, and the total amount of used morphine was noted. Three-month follow-up MRI control was scheduled for all the patients to investigate the infarction rate. Results: Embolisation was performed without any complications and with embolisation of both uterine arteries in all cases. Intra-arterial lidocaine was administered in all 20 patients without complications, and 20 patients in a control group did not receive lidocaine intra-arterial. VAS schemes showed a significant reduction in pain experience 2 h after UFE where mean pain score in the lidocaine group was 42.7 ± 21.4 compared with the control group in which the mean pain score was 61.1 ± 20.4 (p < 0.02). There was no significant difference in pain score 4 h, 7 h, 10 h and 24 h after UFE. In the lidocaine group, the mean amount of used morphine was significantly less with 11.2 mg compared with 20.2 mg in the control group (p < 0.03). Three months of MR follow-up control showed no significant difference in the grade of fibroid infarction. Conclusion: Intra-arterial Lidocaine administration after embolisation is safe and effective in reducing post- procedural pain in the early hours and opioid usage in the first 24 h following UAE. Keywords: Uterine fibroid embolisation, Intraarterial lidocaine, Pain after embolisation, Post-embolization syndrome Introduction UFE is a well known adverse effect of the treatment and Uterine fibroid embolisation (UFE) is a well-described is the most frequent patient complaint (Spencer et al. and well-established interventional radiology procedure 2013). The pain is believed to occur due to temporary to treat symptomatic uterine fibroids. The efficacy and myometrium ischemia after embolisation. The pain usu- long term outcome is documented in several randomised ally starts 1 hour after UFE and increases during the fol- studies and long-term follow-up results are confirmed lowing 5–7 h (Spencer et al. 2013). After that period, the (Hehenkamp et al. 2008; Scheurig-Muenkler et al. 2013; pain usually decreases and the majority of patients are The REST Investigators. 2007). Pain immediately after discharged within 24 h after UFE without pain. Few studies are describing that intra-arterial lidocaine can re- duce the pain during embolisations including UFE * Correspondence: duvnjak.stevo@gmail.com (Noel-Lamy et al. 2017; Keyoung et al. 2001; Lee et al. Department of Radiology, Odense University Hospital, Sdr. Boulevard 29, 2001). Another more invasive analgesic technique to re- 5000 Odense, DK, Denmark Institute for Clinical Research, University of Southern Denmark, Odense, duce or eliminate embolization-induced ischemic pain is Denmark © The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Duvnjak and Andersen CVIR Endovascular (2020) 3:10 Page 2 of 5 hypogastric nerve blockade which has shown promising heart block and active pelvic infection were exclusion results (Binkert et al. 2015; Yoon et al. 2018). criteria. After embolisation, the patients were transferred The present study aims to investigate if intra-arterial to the ward and a visual analogue pain scale (VAS) with lidocaine administrated in the uterine arteries immedi- oral and written instructions was given to the patients ately after UFE reduces the pain. (Bijur et al. 2001). The patients marked their sensation of pain on the VAS at 2 h, 4 h, 7 h, 10 h and 24 h after embol- Materials and methods isation. VAS schemes were collected the following day be- Institutional board and ethical committee approval were fore discharge and the total amount of used morphine was obtained (S-345678). Between August 2017 and July registered as well. Three-month follow-up MRI control 2019, all patients with symptomatic uterine fibroids who follow-up was scheduled for all the patients to investigate accepted participation were block randomised were the infarction rate percentage using the description de- smaller blocks of fewer patients randomised to the two fined as fibroma infarction of 100%, 90–99%, or below treatments at a time intending to have 20 patients in 90% (Duvnjak et al. 2017). Infraction, less than 90% of each group. The patients in one group had 1% 10 ml total fibroid burden, was defined as insufficient. lidocaine (100 mg) administrated intra-arterially immedi- Descriptive statistics were used for baseline patients ately after embolisation in each uterine artery, so the and fibroid characteristics and were presented as num- total doses given to each patient was 200 mg of lido- ber and percentage and as mean and standard deviation caine. In the other (control) group of patients, the pro- (SD). The student’s t-test was used for comparison be- cedure was performed according to standard principles tween the groups regarding the used amount of mor- without supplementary injection of lidocaine. The pa- phine and pain experience. P-value < 0.05 was tient’s age and symptoms, fibroid number, localisation considered statistically significant. SPSS software pack- and total uterine and dominant fibroid volume changes age (Statistics 21, IBM Corporation, Armonk, NY, USA) before and after an embolization were analysed. program was used for analysis. The standard embolisation technique was performed in local anaesthesia via either transfemoral or transradial Results access using diagnostic 5F catheter advanced into the in- Fifty-four consecutive patients were treated with embol- ternal iliac artery. Further, in all cases, micro-catheter isation in the period August 2017 –July 2019 at the De- (Direxion hi-flow 0.027- in., Boston scientific Massachu- partment of Radiology. Fourteen patients did not want setts MA, USA) was used and advanced into the hori- to participate in the study and were excluded. There zontal part of the uterine arteries. Embolisation with were no patients with allergy to lidocaine or morphine microspheres tris-acryl gelatin (500–900 μm) (Embo- or with heart problems. Thus, in all 40 patients were in- sphere, Biosphere Medical, Paris, France) to near stasis cluded in the study and all gave written consent. In all defined as slow forward flow trough the main uterine ar- patients, UFE was performed without complications and tery with at least five heartbeats for clearance of contrast with embolisation of both uterine arteries as intended. from uterine artery with the pruning of peripheral ves- The demography of the patients, baseline fibroid de- sels. The total amount of the used microspheres was re- scription and patient symptoms are presented in Table 1. corded and compared between the groups. All patients There was no statistically significant difference between had patient-controlled analgesia pump (PCA) loaded the lidocaine treated group and the control group in with 2 mg morphine sulphate and an intermittent dose terms of age (p < 0.78), fibroid numbers (p < 0.89), fi- of 1 mg morphine with lockout intervals of 10 min. Be- broid location (p < 0.22), dominant symptoms (p < 0.54), fore the beginning of the embolisation, a loading dose of or amount of used microspheres p < (0.19). Intra-arterial 2 mg morphine was given to all patients. The patients lidocaine was administrated in all 20 patients without were instructed to push the button of the PCA for the complications and was well tolerated. VAS schemes first time before the pain developed. No antibiotics were showed a significant difference in pain experienced be- given and no urinary catheter was deployed. There was tween the groups 2 h after UFE. The median pain experi- no standardised regimen concerning usage of adjunctive enced in the lidocaine group was 45 ± 21.1 compared analgesia and sedation, and if needed, some patients take with the control group 60.1 ± 15.2 (p < 0.02) (Fig. 1). In additional drugs such as non-steroid anti-inflammatory the control group, four patients were not included in the medications on the ward individually. analysis due to either withdrawal from the study (two Inclusion criteria were symptomatic fibroids in a pre- patients) or due to not properly filled-in VAS schemes menopausal woman with bleeding and/or bulky symp- (two patients). There was no difference in pain experi- toms. Size and number of fibroids were not exclusion ence, 4 h, 7 h, 10 h, and 24 h after UFE p < 0.06, p < 0.83, criteria. Patients who did not want to participate in the p < 0.61, p < 0.15). The total amount of used morphine study were excluded. Allergy to morphine or lidocaine, was recorded 24 h after UFE. In the lidocaine group, the Duvnjak and Andersen CVIR Endovascular (2020) 3:10 Page 3 of 5 Table 1 Pre-embolization patients and fibroid characteristics Lidocaine group Control group p-value Mean age (years-SD) 44.4 ± 3.3 43.1 ± 5.11 p < 0.78 3 3 Dominant fibroid volume (mean-SD) 183.1 ± 206.5 cm 262.8 ± 188.7 cm p < 0.26 Singular fibroid n = 9 (45%) n = 7 (44%) 2–5 fibroids n = 4 (20%) n = 6 (37%) > 5 fibroids n = 7 (35%) n = 3 (19%) Dominant symptom p < 0.54 Bleeding symptoms n = 11 (55%) n = 6 (37%) Bulk symptoms n = 5 (25%) n = 7 (44%) Both bleedings and bulk symptoms n = 4 (20%) n = 3 (19%) mean amount of used morphine was 11.2 mg compared significant difference in terms of fibroid infarction with 20.2 mg in the control group (p < 0.03). The de- between the groups (Table 3). tailed scores of the pain experience and comparison be- tween the groups and the use of morphine are presented Discussion in Table 2. All patients were discharged about 24 h after The present randomised study confirmed that intra- UFE and continued on non-steroid anti-inflammatory arterial lidocaine administration after UFE reduce the medication. Three patients (two in the lidocaine group pain in the first hours after embolisation. Lidocaine has and one in the control group) phoned back due to pain a half-life about 90–120 min, and the effect was con- experienced on day three after UFE, but there were no firmed in this study during the first 2 hours after UFE. re-admissions to hospital after discharge. No complica- Noel-Lamy et al. 2017, showed in prospective study tions or readmissions occurred during 3 months of similar results with the maximal effect and pain control follow-up in any group. Three-month follow-up MRI in within two to 4 hours after UFE. In another study, control was obtained in 36 patients and showed no pain control was achieved in a longer period after UFE Fig. 1 Boxplot showing the significant difference in a median pain Duvnjak and Andersen CVIR Endovascular (2020) 3:10 Page 4 of 5 Table 2 The pain experience and used of morphine -comparison between the groups Lidocaine group Control group p-value Pain experience 2 h after UFE (mean-SD) 42.7 ± 21.4 61.1 ± 20.4 p < 0.02 Pain experience 4 h after UFE (mean-SD) 39.7 ± 23.1 53.7 ± 21 p < 0.06 Pain experience 7 h after UFE (mean-SD) 41.5 ± 20.8 42.8 ± 15.4 p < 0.83 Pain experience 10 h after UFE (mean-SD) 34.7 ± 19.6 31.8 ± 12.5 p < 0.61 Pain experience 24 h after UFE (mean-SD) 20.7 ± 14.5 27.3 ± 12.5 p < 0.15 Total amount of used morphine mean value (mg-SD) 11.2 ± 7.3 (range: 4–32) 20.2 ± 10.8 (range:10–44) p < 0.03 but the methodology was not the same as in the present investigation demonstrates that this technique works, study (Kim et al. 2008). Katsumori et al. 2020, in his but this is a subjective opinion. In this study embolisa- study, did not achieve significant statistical difference tion endpoint was sluggish forward flow and we admin- comparing the patients who received intra-arterial lido- istrated lidocaine over 30–60 s very slowly. Control MR caine and those who did not get the lidocaine. This imaging showed similar results compared with a control study was retrospective including the patients treated group allowing us to conclude that this technique is effi- with embolisation from 2014 to 2019. The amount of cient. The administration of lidocaine before or together used lidocaine was 80 mg comparing to our study, where with microspheres might reduce the fibroid infarction 200 mg lidocaine was used that can probably explain the rate and thus not end-up with an optimal result and different outcome. Zhan et al. 2005, used in his study 40 therefore is not recommended (Noel-Lamy et al. 2017; mg od lidocaine and showed significant pain reduction Keyoung et al. 2001). All patients had a PCA pump despite the small amount of the drug in the patients allowing us to record the total amount of morphine who received lidocaine but the used microparticles and which is an advantage compared with another similar time to record pain was different than in our study. study (Noel-Lamy et al. 2017). Hypogastric nerve block- Further, Katsumori et al. 2020 recorded the VAS pain ade is invasive and according to the literature not com- during the embolisation and first, 3 hours after the inter- plicated to learn (Binkert et al. 2015). However, vention. The maximal effect of intra-arterial lidocaine is intraarterial lidocaine administration is a simpler less- in the first 2 hours due to the half-life of the drug. invasive technique than hypogastric nerve blockade with The pain experienced in our study was lower com- a likely lesser learning curve and could be widely pared with the control group after 4 h,7 h,10 h, and 24 h adopted more easily. Therefore, very simple intraarterial but without statistical significance, similar to Katsumori lidocaine administration in total doses of 200 mg is pref- et al. 2020 study confirming that lidocaine has the max- erable in our opinion despite the limited long-term pain imal effect in the first 2 hours. effect due to lidocaine metabolism. A recent published The intra-arterial lidocaine administration was safe in systemic review emphasises the need for more evidence, all patients without any complaints and adverse events and no clear advantage of any of the used methods for and was easy and safe to deliver after the embolisation pain control after UFE have been demonstrated so far endpoint was achieved. In previously published studies, (Saibudeen et al. 2019). there were no reported cases of adverse reactions during The limitation of this study are small number of the the intraarterial lidocaine administration as well (Noel- patients, not double-blinded design and drop-out of four Lamy et al. 2017; Keyoung et al. 2001; Lee et al. 2001). patients that withdrew or did not fill in the VAS schema When the embolisation endpoint is achieved, injection properly. Further, different access via transfemoral or of lidocaine might theoretically reflux backwards into transradial access could be a possible confounding factor other vessels, but it seems not to be the case as present due to early mobilisation after transradial access and Table 3 Detail about used microspheres and MR three months control results Lidocaine group Control group p-value The total amount of used microspheres (ml- SD) 6.9 ± 2.5 9.7 ± 2.8 p < 0.19 3 3 Dominant fibroid volume reduction (three months control) 84.4 ± 92 cm 145.1 ± 175 cm p < 0.15 3 3 Total uterine volume 161,7 ± 154 cm 261,9 ± 288 cm P < 0.26 Total fibroid burden infarction p < 0.86 100% or 90–99%-fibroid infraction 18 (94%) 14 (95%) < 90% fibroid infarction 2 (6%) 2 (5%) Duvnjak and Andersen CVIR Endovascular (2020) 3:10 Page 5 of 5 eventualy use of additional non-steroid anti-inflammatory with Trisacryl gelatin microspheres for leiomyoma. J Vasc Interv Radiol 31: 114–120 drugs in the immediately post-embolisation period. Finally, Keyoung JA, Levy EB, Roth AR, Gomez-Jorge J, Chang TC, Spies JB (2001) the specific size and volume of used embosphere was not Intraarterial lidocaine for pain control after uterine artery embolization for standardised or analysed systematically. leiomyomata. J Vasc Interv Radiol 12:1065–1069 Kim HS, Czuczman GJ, Nicholson WK, Pham LD, Richman JM (2008) Pain levels within 24 hours after UFE:a comparison of morphine and fentanyl patient- Conclusion controlled analgesia. Cardiovasc Intervent Radiol 31:1100–1107 Intra-arterial Lidocaine administration after embolisation Lee SH, Hahn ST, Park SH (2001) Intraarterial lidocaine administration for relief of pain resulting from transarterial chemoembolization of hepatocellular is safe and effective in reducing post-procedural pain in carcinoma: its effectiveness and optimal timing of administration. Cardiovasc the early hours and opioid usage in the first 24 h follow- Intervent Radiol 24:368–371 ing UAE. Further studies of how further to reduce pain Noel-Lamy M, Tan KT, Simons ME, Sniderman KW, Mironov O, Rajan DK (2017) Intraarterial Lidocaine for Pain Control in Uterine Artery Embolization: A are warranted. Prospective, Randomized Study. J Vasc Interv Radiol 28:16–22 Saibudeen A, Makris GC, Elzein A et al (2019) Pain management protocol during Abbreviations uterine fibroid embolization: a systematic review of the evidence. Cardiovasc F: French; MR: Magnentic resonance; PCA: Patient-controlled analgesia pump; Intervent Radiol. https://doi.org/10.1007/s00270-019-02327-1 [Epub ahead of UFE: Uterine fibroid embolization; VAS: Visual analogue scale print] Scheurig-Muenkler C, Koesters C, Powerski MJ, Grieser C, Froeling V, Kroencke TJ Acknowledgments (2013) Clinical long-term outcome after uterine artery embolization: Not applicable. sustained symptom control and improvement of quality of life. J Vasc Interv Radiol 24(6):765–771 Authors’ contributions Spencer EB, Stratil P, Mizones H (2013) Clinical and periprocedural pain SD performed the procedures, collect the data and perform, analysis, and management for uterine fibroid embolization. Semin Interv Radiol 30:354–363 manuscript preparation. PEA assisted with data analysis and manuscript The REST Investigators (2007) Uterine-artery embolization versus surgery for preparation. Both authors read and approved the final manuscript. symptomatic uterine fibroids. NEJM 356:360–370 Yoon J, Valenti D, Muchantef K et al (2018) Superior Hypogastric Nerve Block as Funding Post-Uterine Artery Embolization Analgesia: A Randomized and Double-Blind This study was not supported by any funding. Clinical Trial. Radiology 289:248–254 Zhan S, Li Y, Wang G, Han H, Yang Z (2005) Effectiveness of intra-arterial Availability of data and materials anesthesia for uterine fibroid embolization using dilute lidocaine. Eur Radiol The datasets analyzed during the current study are available from the 15:1752–1756 corresponding author on reasonable request. Ethics approval and consent to participate Publisher’sNote All procedures performed in studies involving human participants were in Springer Nature remains neutral with regard to jurisdictional claims in accordance with the ethical standards of the institutional and/or national published maps and institutional affiliations. research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This project was reviewed by the NYU Winthrop Hospital Institutional Review Board and given approval. Informed consent was obtained from all patients in the study. Consent for publication Consent for publication was obtained for every individual person’s data included in the study. Informed consent was obtained from all patients in the study. Competing interests Stevo Duvnjak (SD) declares following COI- Advisory Board Boston Scientific and paid lectures –Medtronic. Poul Erik Andersen (PEA) declare that they have no conflict of interest. Received: 20 November 2019 Accepted: 13 January 2020 References Bijur PE, Silver W, Gallagher EJ (2001) Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med 8:1153–1157 Binkert CA, Hirzel FC, Gutzeit A, Zollikofer CL, Hess T (2015) Superior Hypogastric Nerve Block to Reduce Pain After Uterine Artery Embolization: Advanced Technique and Comparison to Epidural Anesthesia. Cardiovasc Intervent Radiol 38:1157–1161 Duvnjak S, Ravn P, Green A, Andersen PE (2017) Uterine fibroid embolization with acrylamido polyvinyl microspheres: prospective 12-month clinical and MRI follow-up study. Acta Radiol 58:952–958 Hehenkamp WJ, Volkers NA, Birnie E, Reekers JA, Ankum WM (2008) Symptomatic uterine fibroids: treatment with uterine artery embolization or hysterectomy—results from the randomized clinical embolisation versus hysterectomy (EMMY) trial. Radiology 246:823–832 Katsumori T, Miura H, Yoshikawa T, Seri S, Kotera Y, Asato A (2020) Intra-arterial Lidocaine Administration for Anesthesia after uterine artery embolization

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CVIR EndovascularSpringer Journals

Published: Feb 10, 2020

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