Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

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.

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.

Criteria:

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.

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

UHN research ethics board contact information

Description of uterine fibroid embolization procedure

Related publications:

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