Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization : a Single-center Prospective Randomized Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Post-Procedural Pain at 4 hours
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Lidocaine per-embolization
This group will receive 10mL of 1% lidocaine in both uterine artery during the embolization; the lidocaine will be mixed with the embolization particles.
Intervention: Lidocaine per-embolization (Drug)
Lidocaine post-embolization
10mL of 1% lidocaine will be injected in both uterine arteries after embolization endpoint is achieved.
Intervention: Lidocaine post-embolization (Drug)
Outcomes
Primary Outcomes
Post-Procedural Pain at 4 hours
Time Frame: 4h post-procedure
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.
Post-Procedural Pain at 7 hours
Time Frame: 7h post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
Secondary Outcomes
- Narcotic dose(24 hours post-intervention)
- Hospital length-of-stay(24 hours post-intervention)
- Post-Procedural Pain at 24 hours(24 hours post-procedure)
Investigators
Dheeraj Rajan
Attending Interventional Radiologist and Associate Professor
University Health Network, Toronto