CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Lidocaine per-embolization +1 moredrug
Likely dose
Lidocaine per-embolization 10mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02293447
NCT02293447Phase 4Completed

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

University Health Network, Toronto·interventional·Posted Nov 18, 2014·Updated May 12, 2016

In Brief

A Phase 4 clinical trial evaluating Lidocaine per-embolization and Lidocaine post-embolization for Uterine Leiomyomas. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 18, 2014
Enrollment StartNov 1, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.6 years ago

Interventions

Lidocaine per-embolizationdrug

10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.

Lidocaine post-embolizationdrug

10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.