Clinical trial NCT02293447: Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization
Official title: Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization : a Single-center Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Leiomyomas
Keywords: Uterine
Fibroid
Embolization
Leiomyoma
Lidocaine
Pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Post-Procedural Pain at 4 hours
timeFrame: 4h post-procedure
measure: Post-Procedural Pain at 7 hours
timeFrame: 7h post-procedure
Secondary outcomes:
measure: Hospital length-of-stay
timeFrame: 24 hours post-intervention
measure: Narcotic dose
timeFrame: 24 hours post-intervention
measure: Post-Procedural Pain at 24 hours
timeFrame: 24 hours post-procedure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Dheeraj Rajan, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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