Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization
- Conditions
- Uterine Leiomyomas
- Interventions
- Registration Number
- NCT02293447
- Lead Sponsor
- University Health Network, Toronto
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine post-embolization Lidocaine post-embolization 10mL of 1% lidocaine will be injected in both uterine arteries after embolization endpoint is achieved. Lidocaine per-embolization 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.
- Primary Outcome Measures
Name Time Method Post-Procedural Pain at 4 hours 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 7h post-procedure Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
- Secondary Outcome Measures
Name Time Method Narcotic dose 24 hours post-intervention The total amount on narcotic doses administered to patient during the first 24hours post-procedure will be recorded.
Hospital length-of-stay 24 hours post-intervention Estimated in hours, the length-of-stay will be evaluated from the end of procedure to discharge.
Post-Procedural Pain at 24 hours 24 hours post-procedure Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
Trial Locations
- Locations (1)
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada