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Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uterine Leiomyomas

Intervention: Lidocaine per-embolization (Drug); Lidocaine post-embolization (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Dheeraj Rajan, MD, FRCPC, Principal Investigator, Affiliation: University Health Network, Toronto

Overall contact:
Maxime Noel-Lamy, MD, FRCPC, Phone: 416-946-4501, Ext: 5054, Email: maxime.noel-lamy@uhn.ca


Uterine artery embolization (UAE) is a minimally invasive treatment for women with symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms improvement, with fewer complications and at lower cost. However, the majority of women undergoing UFE experience important pain after the procedure despite optimal analgesia, with one third reporting pain equal or worse than labor. Pain is the more common cause of prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce post-procedural pain. For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine, injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3 groups: control, lidocaine injected during embolization, and lidocaine injected after embolization. Pain will be evaluated using a validated scale at 4h and 24h post-intervention. Hospital length-of-stay and total narcotic dose administered will be evaluated in the three groups. This is the first Canadian study evaluating lidocaine use for pain control in UFE patients. Results will be transferable to clinical practice, considering the use of lidocaine is simple and cost is negligible. It could have a great impact on pain management in women undergoing UFE in all practice settings.

Clinical Details

Official title: Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization : a Single-center Prospective Randomized Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Primary outcome:

Post-Procedural Pain at 4 hours

Post-Procedural Pain at 7 hours

Secondary outcome:

Hospital length-of-stay

Narcotic dose

Post-Procedural Pain at 24 hours


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Indication for uterine fibroid embolization: bulk symptoms, pain or heavy menstrual

bleeding attributed to fibroids, with imaging confirmation;

- Patient must be able to provide written, informed consent

Exclusion Criteria:

- Documented of allergy or intolerance to lidocaine or other amide-type anesthetics;

- Personal or familial history of malignant familial hyperthermia;

- Documented history of second or third atrio-ventricular heart block

- Contra-indication to uterine fibroid embolization : active infection, suspected

malignancy, coagulopathy, pregnancy or desire to preserve fertility, large pedunculated sub-serosal fibroid.

- History of previous uterine fibroid embolization.

Locations and Contacts

Maxime Noel-Lamy, MD, FRCPC, Phone: 416-946-4501, Ext: 5054, Email: maxime.noel-lamy@uhn.ca

Toronto Western Hospital, Toronto, Ontario M5T 2S8, Canada; Recruiting
Dheeraj Rajan, MD, FRCPC, Principal Investigator
Maxime Noel-Lamy, MD, FRCPC, Sub-Investigator
Additional Information

UHN research ethics board contact information

Description of uterine fibroid embolization procedure

Related publications:

Keyoung JA, Levy EB, Roth AR, Gomez-Jorge J, Chang TC, Spies JB. Intraarterial lidocaine for pain control after uterine artery embolization for leiomyomata. J Vasc Interv Radiol. 2001 Sep;12(9):1065-9.

Zhan S, Li Y, Wang G, Han H, Yang Z. Effectiveness of intra-arterial anesthesia for uterine fibroid embolization using dilute lidocaine. Eur Radiol. 2005 Aug;15(8):1752-6. Epub 2005 Feb 5.

Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003 Jan;188(1):100-7.

Pinto I, Chimeno P, Romo A, Paúl L, Haya J, de la Cal MA, Bajo J. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment--a prospective, randomized, and controlled clinical trial. Radiology. 2003 Feb;226(2):425-31.

Hehenkamp WJ, Volkers NA, Donderwinkel PF, de Blok S, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial. Am J Obstet Gynecol. 2005 Nov;193(5):1618-29.

Hehenkamp WJ, Volkers NA, Birnie E, Reekers JA, Ankum WM. Symptomatic uterine fibroids: treatment with uterine artery embolization or hysterectomy--results from the randomized clinical Embolisation versus Hysterectomy (EMMY) Trial. Radiology. 2008 Mar;246(3):823-32. doi: 10.1148/radiol.2463070260. Epub 2008 Jan 9.

Volkers NA, Hehenkamp WJ, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids: 2 years' outcome from the randomized EMMY trial. Am J Obstet Gynecol. 2007 Jun;196(6):519.e1-11.

Ananthakrishnan G, Murray L, Ritchie M, Murray G, Bryden F, Lassman S, Lumsden MA, Moss JG. Randomized comparison of uterine artery embolization (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): subanalysis of 5-year MRI findings. Cardiovasc Intervent Radiol. 2013 Jun;36(3):676-81. doi: 10.1007/s00270-012-0485-y. Epub 2012 Oct 16.

Edwards RD, Moss JG, Lumsden MA, Wu O, Murray LS, Twaddle S, Murray GD; Committee of the Randomized Trial of Embolization versus Surgical Treatment for Fibroids. Uterine-artery embolization versus surgery for symptomatic uterine fibroids. N Engl J Med. 2007 Jan 25;356(4):360-70.

Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, Craig LE, Lumsden MA. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG. 2011 Jul;118(8):936-44. doi: 10.1111/j.1471-0528.2011.02952.x. Epub 2011 Apr 12.

Spencer EB, Stratil P, Mizones H. Clinical and periprocedural pain management for uterine artery embolization. Semin Intervent Radiol. 2013 Dec;30(4):354-63. doi: 10.1055/s-0033-1359729. Review.

Pron G, Bennett J, Common A, Wall J, Asch M, Sniderman K; Ontario Uterine Fibroid Embolization Collaboration Group. The Ontario Uterine Fibroid Embolization Trial. Part 2. Uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fertil Steril. 2003 Jan;79(1):120-7.

Walker WJ, Pelage JP. Uterine artery embolisation for symptomatic fibroids: clinical results in 400 women with imaging follow up. BJOG. 2002 Nov;109(11):1262-72.

van der Kooij SM, Moolenaar LM, Ankum WM, Reekers JA, Mol BW, Hehenkamp WJ. Epidural analgesia versus patient-controlled analgesia for pain relief in uterine artery embolization for uterine fibroids: a decision analysis. Cardiovasc Intervent Radiol. 2013 Dec;36(6):1514-20. doi: 10.1007/s00270-013-0607-1. Epub 2013 Apr 11.

Rasuli P, Jolly EE, Hammond I, French GJ, Preston R, Goulet S, Hamilton L, Tabib M. Superior hypogastric nerve block for pain control in outpatient uterine artery embolization. J Vasc Interv Radiol. 2004 Dec;15(12):1423-9.

Guthaner DF, Silverman JF, Hayden WG, Wexler L. Intraarterial analgesia in peripheral arteriography. AJR Am J Roentgenol. 1977 May;128(5):737-9.

Widrich WC, Singer RJ, Robbins AH. The use of intra-arterial lidocaine to control pain due to aortofemoral arteriography. Radiology. 1977 Jul;124(1):37-41.

Widrich WC, Robbins AH, Goldstein SA, Singer RJ. Adjuvant intra-arterial lidocaine in aortofemoral arteriography: some further observations. Radiology. 1978 Nov;129(2):371-3.

Cranston PE. Lidocaine analgesia in peripheral angiography: a confirmation of effectiveness. South Med J. 1982 Oct;75(10):1229-31.

Gordon IJ, Westcott JL. Intra-arterial lidocaine: an effective analgesic for peripheral angiography. Radiology. 1977 Jul;124(1):43-5.

Molgaard CP, Teitelbaum GP, Pentecost MJ, Finck EJ, Davis SH, Dziubinski JE, Daniels JR. Intraarterial administration of lidocaine for analgesia in hepatic chemoembolization. J Vasc Interv Radiol. 1990 Nov;1(1):81-5.

Hartnell GG, Gates J, Stuart K, Underhill J, Brophy DP. Hepatic chemoembolization: effect of intraarterial lidocaine on pain and postprocedure recovery. Cardiovasc Intervent Radiol. 1999 Jul-Aug;22(4):293-7.

Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16. Review.

Pron G, Mocarski E, Bennett J, Vilos G, Common A, Zaidi M, Sniderman K, Asch M, Kozak R, Simons M, Tran C, Kachura J; Ontario UFE Collaborative Group. Tolerance, hospital stay, and recovery after uterine artery embolization for fibroids: the Ontario Uterine Fibroid Embolization Trial. J Vasc Interv Radiol. 2003 Oct;14(10):1243-50.

Starting date: November 2014
Last updated: June 11, 2015

Page last updated: August 23, 2015

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