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

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyomas

• NCT number: NCT02293447
• Study type: Interventional
• Source: University Health Network, Toronto
• Contact: Maxime Noel-Lamy, MD, FRCPC
• Phone: 416-946-4501
• Email: maxime.noel-lamy@uhn.ca
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2014
• Completion date: April 2016