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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
60
10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.
10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.
Toronto Western Hospital
Toronto, Ontario, Canada
Post-Procedural Pain at 4 hours
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.
Time frame: 4h post-procedure
Post-Procedural Pain at 7 hours
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
Time frame: 7h post-procedure
Hospital length-of-stay
Estimated in hours, the length-of-stay will be evaluated from the end of procedure to discharge.
Time frame: 24 hours post-intervention
Narcotic dose
The total amount on narcotic doses administered to patient during the first 24hours post-procedure will be recorded.
Time frame: 24 hours post-intervention
Post-Procedural Pain at 24 hours
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
Time frame: 24 hours post-procedure
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