28 Participants Needed

Steroid-Enhanced Nerve Block for Uterine Fibroids Pain Relief

Recruiting at 1 trial location
HP
ML
TL
SC
Overseen BySaima Chaabane
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the steroid-enhanced nerve block treatment generally safe for humans?

Bupivacaine (Marcaine), used in various forms of anesthesia, has been shown to be generally safe with minimal side effects when used in recommended doses. In a review of 11,080 cases, only 15 systemic toxic reactions occurred, all without lasting negative effects, indicating a good safety profile when used correctly.12345

How does the drug Bupivacaine differ from other treatments for uterine fibroids pain relief?

Bupivacaine is unique because it is a long-acting local anesthetic that provides pain relief by blocking nerve signals, and it is often used in epidural anesthesia with minimal side effects. This makes it different from other treatments for uterine fibroids, which may not focus on nerve block techniques for pain management.12346

What data supports the effectiveness of the drug used in the Steroid-Enhanced Nerve Block for Uterine Fibroids Pain Relief?

Research shows that bupivacaine (Marcaine) is effective as a local anesthetic in various medical procedures, providing good pain relief with minimal side effects, especially when used in obstetrics and surgeries like lumbar disc herniation.12367

Who Is on the Research Team?

JK

Jessica K Stewart, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for women aged 30-60 with painful uterine fibroids or adenomyosis who are scheduled for a Uterine Artery Embolization (UAE) procedure. It's not suitable for those with conditions making UAE unsafe, bleeding disorders, diabetes, allergies to anesthetics or steroids, and certain bowel diseases.

Inclusion Criteria

I am between 30 and 60 years old.
I am female.
I am diagnosed with uterine fibroids or adenomyosis and will have a UAE procedure.

Exclusion Criteria

My doctor says a nerve block is unsafe for me.
I have diabetes.
I do not have any conditions that prevent me from undergoing UAE.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Uterine Artery Embolization (UAE) procedure with a Superior Hypogastric Nerve Block (SHNB) using either bupivacaine with triamcinolone or bupivacaine alone

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain intensity and medication use post-procedure

10 days
Online surveys at multiple time points

What Are the Treatments Tested in This Trial?

Interventions

  • Bupivacaine
  • Triamcinolone
Trial Overview The study tests if adding steroids to the Superior Hypogastric Nerve Block (SHNB), part of the UAE procedure, affects post-procedure pain and need for painkillers. Participants will receive SHNB with either Bupivacaine alone or combined with Triamcinolone.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Bupivacaine and TriamcinoloneExperimental Treatment3 Interventions
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine plus triamcinolone mixed with contrast to enable visualization of the nerve block under fluoroscopy.
Group II: BupivacaineActive Control2 Interventions
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Marcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia
🇪🇺
Approved in European Union as Marcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia
🇨🇦
Approved in Canada as Sensorcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Published Research Related to This Trial

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.
When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.
[The use of Marcaine in obstetrical analgesia].Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]
Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.
Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.
Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology.Duka, M., Lazić, Z., Stamatović, N., et al.[2019]
In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.
Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.
[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia].Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

Citations

0.125% bupivacaine for obstetric analgesia? [2019]
[The use of Marcaine in obstetrical analgesia]. [2013]
Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]
4.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]
Preventive Effects of Pre- and Intra-operative Marcaine, Lidocaine, and Marcaine Plus Lidocaine on Pain Relief in Lumbar Disc Herination Open Surgery. [2022]
Bupivacaine: a review of 11,080 cases. [2019]
The bupivacaine paracervical block in labor and its effect on quantitative uterine activity. [2013]
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