Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Leiomyomas

Intervention / Treatment
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* Drug: Lidocaine per-embolization
* Drug: Lidocaine post-embolization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group will undergo uterine artery embolization according to regular protocol, without the administration of lidocaine. | |
| Experimental: Lidocaine per-embolization<br>This group will receive 10mL of 1% lidocaine in both uterine artery during the embolization; the lidocaine will be mixed with the embolization particles. | Drug: Lidocaine per-embolization<br>* 10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.<br>* Other names: 00884154;|
| Experimental: Lidocaine post-embolization<br>10mL of 1% lidocaine will be injected in both uterine arteries after embolization endpoint is achieved. | Drug: Lidocaine post-embolization<br>* 10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.<br>* Other names: 00884154;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4h post-procedure | 
| Post-Procedural Pain at 7 hours | Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS) | 7h post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length-of-stay | Estimated in hours, the length-of-stay will be evaluated from the end of procedure to discharge. | 24 hours post-intervention | 
| Narcotic dose | The total amount on narcotic doses administered to patient during the first 24hours post-procedure will be recorded. | 24 hours post-intervention | 
| Post-Procedural Pain at 24 hours | Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS) | 24 hours post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine, Fibroid, Embolization, Leiomyoma, Lidocaine, Pain