Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

May 10, 2016 updated by: Dheeraj Rajan, University Health Network, Toronto

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The control group will undergo uterine artery embolization according to regular protocol, without the administration of lidocaine.
Experimental: 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.
Drug: Lidocaine per-embolization
10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.
Other Names:
  • Lidocaine hydrochloride
  • Local anesthetic
  • Amide-type anesthetic
  • 00884154
Experimental: Lidocaine post-embolization
10mL of 1% lidocaine will be injected in both uterine arteries after embolization endpoint is achieved.
Drug: Lidocaine post-embolization
10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.
Other Names:
  • Lidocaine hydrochloride
  • Local anesthetic
  • Amide-type anesthetic
  • 00884154

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Procedural Pain at 4 hours
Time Frame: 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.
4h post-procedure
Post-Procedural Pain at 7 hours
Time Frame: 7h post-procedure
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
Time Frame: 24 hours post-intervention
Estimated in hours, the length-of-stay will be evaluated from the end of procedure to discharge.
24 hours post-intervention
Narcotic dose
Time Frame: 24 hours post-intervention
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
Time Frame: 24 hours post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
24 hours post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Dheeraj Rajan, MD, FRCPC, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-8053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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