Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

University Health Network, Toronto

Status and phase: Completed; Phase 4

Conditions: Uterine Leiomyomas

Treatments: Drug: Lidocaine per-embolization; Drug: Lidocaine post-embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02293447

14-8053

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

Control

No Intervention group

Description:

The control group will undergo uterine artery embolization according to regular protocol, without the administration of lidocaine.

Lidocaine per-embolization

Experimental group

Description:

This group will receive 10mL of 1% lidocaine in both uterine artery during the embolization; the lidocaine will be mixed with the embolization particles.

Treatment:

Drug: Lidocaine per-embolization

Lidocaine post-embolization

Experimental group

Description:

10mL of 1% lidocaine will be injected in both uterine arteries after embolization endpoint is achieved.

Treatment:

Drug: Lidocaine post-embolization