Steroid-Enhanced Nerve Block for Uterine Fibroids Pain Relief

Not currently recruiting at 2 trial locations

Overseen By Saima Chaabane

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Inflammatory bowel disease, Ulcerative colitis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a nerve block with a steroid for pain relief in women with uterine fibroids undergoing a Uterine Artery Embolization (UAE) procedure. It compares two treatments: one group receives bupivacaine (a local anesthetic) combined with the steroid triamcinolone, while the other group receives only bupivacaine. The trial focuses on differences in pain levels and the need for painkillers after the procedure. Women aged 30–60 with painful uterine fibroids scheduled for UAE may be suitable candidates for this study. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking medical research.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using bupivacaine with triamcinolone in nerve block procedures can effectively manage pain. Some studies have found that adding triamcinolone, a type of steroid, to bupivacaine extends the duration of pain relief without causing major issues. Patients in these studies did not report significant side effects from the treatment.

Bupivacaine alone is a well-known pain reliever used in many medical procedures and is usually safe when used correctly. In studies related to uterine artery embolization, bupivacaine for pain control did not lead to major complications. Adding triamcinolone aims to prolong the pain relief.

Since this study is in an early phase, it focuses on ensuring the treatment's safety and understanding any possible side effects in a controlled environment. While the treatment is generally considered safe, this phase will provide more detailed information about its tolerance when used together in this specific procedure. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the steroid-enhanced nerve block for uterine fibroids because it offers a novel way to manage pain. Unlike standard treatments like NSAIDs or hormonal therapies, this approach uses a combination of bupivacaine and triamcinolone to directly target nerves during the Uterine Artery Embolization procedure. This technique allows for precise visualization and delivery of the pain relief, potentially offering quicker and more effective results. The addition of triamcinolone, a steroid, could enhance and prolong the pain-relieving effects compared to bupivacaine alone.

What evidence suggests that this trial's treatments could be effective for uterine fibroids pain relief?

Research has shown that bupivacaine effectively relieves pain during various procedures as a local anesthetic. In this trial, participants will be assigned to different treatment arms to evaluate pain management after uterine artery embolization, a treatment for uterine fibroids. One arm will receive bupivacaine alone, while another will receive a combination of bupivacaine and triamcinolone, a type of steroid. Studies have found that adding triamcinolone to bupivacaine can extend the duration of pain relief after certain procedures. The addition of the steroid aims to provide longer-lasting pain relief compared to bupivacaine alone. This approach is based on early observations, with the hope of reducing pain and the need for narcotic painkillers. ^{1 5 6 7 8}

Who Is on the Research Team?

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.

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?

Group I: Bupivacaine and Triamcinolone Experimental Treatment 3 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: Bupivacaine Active Control 2 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

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

Bupivacaine, used in various concentrations (0.25%, 0.5%, 0.75%) for different types of anesthesia, consistently provided complete sensory anesthesia for a wide range of surgical procedures, with onset times of 4 to 10 minutes and maximum effect in 15 to 35 minutes.

While there were 15 reported systemic toxic reactions, none led to lasting harm, indicating that Bupivacaine can be used safely in clinical settings, although careful monitoring is necessary, especially with higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. Moore, DC., Bridenbaugh, LD., Thompson, GE., et al.[2019]

Citations

1. withpower.com withpower.com/trial/early-phase-1-leiomyoma-10-2019-8886f

Steroid-Enhanced Nerve Block for Uterine Fibroids Pain ... Research shows that bupivacaine (Marcaine) is effective as a local anesthetic in various medical procedures, providing good pain relief with minimal side ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8354709/

Managing Postembolization Syndrome–Related Pain after ... Moreover, some studies have shown that the addition of steroids (40 mg of triamcinolone to 20 mL of 0.5% bupivacaine block) can prolong the duration of SHNB ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2900018/

Efficacy of triamcinolone acetonide and bupivacaine for ... The study is a prospective blinded randomised controlled trial to compare the efficacy of triamcinolone acetonide, bupivacaine or in combination in managing

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0066337

Uterine Fibroids (Leiomyomas) (DBCOND0066337) A gonadotropin releasing hormone receptor antagonist used to treat moderate to severe pain in endometriosis. Gonadotropin-releasing hormone receptortarget ...

5. researchgate.net researchgate.net/publication/341128877_Superior_Hypogastric_Nerve_Block_for_Pain_Control_after_Uterine_Artery_Embolization_Effect_of_Addition_of_Steroids_on_Analgesia

Superior Hypogastric Nerve Block for Pain Control after Uterine ... Uterine artery embolization (UAE) has been shown to be a safe and effective treatment for symptomatic uterine fibroids, with over 25 years of supporting data.

6. go.drugbank.com go.drugbank.com/drugs/DB00620/clinical_trials?conditions=DBCOND0111328%2CDBCOND0066337&phase=0&purpose=treatment&status=active_not_recruiting

Triamcinolone Active Not Recruiting Phase 0 Trials for Internal ... Triamcinolone Active Not Recruiting Phase 0 Trials for Internal Endometriosis / Uterine Fibroids (Leiomyomas) Treatment ; NCT04126824. Effect of Addition of ...

7. clinicaltrials.gov clinicaltrials.gov/search?cond=%22Leiomyoma,%20Uterine%22&intr=%22Anti-Inflammatory%20Agents%22&viewType=Table&rank=6

Search for: "Leiomyoma, Uterine", "Anti-Inflammatory Agents" A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

8. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT04126824

Addition of Steroids on Duration of Analgesia - UC Clinical Trials This Uterine Fibroids and Adenomyosis study at University of California Health ends February 2026.