Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

Uterine Leiomyomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02293447
• Other study ID #: 14-8053
• Status: Recruiting
• Phase: Phase 4
• First received: November 10, 2014
• Last updated: June 11, 2015
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2015
• Source: University Health Network, Toronto
• Contact: Maxime Noel-Lamy, MD, FRCPC
• Phone: 416-946-4501
• Email: maxime.noel-lamy[@]uhn.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyomas

Intervention

Drug:
• Lidocaine per-embolization
10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.
• Lidocaine post-embolization
10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Procedural Pain at 4 hours	Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS) filled by patients at 4h, 7h and 24h post-procedure. At 4h, patients will report the worst pain they experienced since end of procedure. At 7h and 24h, pain at time of assessment will be recorded.	4h post-procedure	No
Primary	Post-Procedural Pain at 7 hours	Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)	7h post-procedure	No
Secondary	Hospital length-of-stay	Estimated in hours, the length-of-stay will be evaluated from the end of procedure to discharge.	24 hours post-intervention	No
Secondary	Narcotic dose	The total amount on narcotic doses administered to patient during the first 24hours post-procedure will be recorded.	24 hours post-intervention	No
Secondary	Post-Procedural Pain at 24 hours	Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)	24 hours post-procedure	No

External Links

•   Description of uterine fibroid embolization procedure
•   UHN research ethics board contact information