Skip to main content
OpenTrials
Completed

NCT Number: NCT02293447

Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine per-embolization

Drug

10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.

Other names: Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 00884154

Lidocaine post-embolization

Drug

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

Other names: Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 00884154

Primary outcomes

  1. 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.

  2. Post-Procedural Pain at 7 hours

    Time frame: 7h post-procedure

    Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)

Secondary outcomes

  1. 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.

  2. 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.

  3. Post-Procedural Pain at 24 hours

    Time frame: 24 hours post-procedure

    Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2014
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.