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Local Anesthetic

Steroid-Enhanced Nerve Block for Uterine Fibroids Pain Relief

Q: May I be accepted as a participant in this medical research?

This clinical trial seeks 28 patients that are between the ages of 30 and 60 with a diagnosis of adenomyosis.

Q: What medical conditions have been known to respond positively to Triamcinolone treatment?

Typically, Triamcinolone is administered to address permphigus. However, this drug has also been found successful in treating <a href="https://www.withpower.com/clinical-trials/lupus">lupus</a> erythematosus cell, <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a> and hand-related conditions.

Q: How many individuals have enrolled in the clinical trial thus far?

Affirmative, the details present on clinicaltrials.gov verify that this trial is actively enrolling individuals. First posted in November 5th 2019 and most recently edited March 25th 2022, it is looking for 28 test subjects from a single site.

Q: Is there still an opportunity to be part of this research endeavor?

Affirmative, the clinical trial is still recruiting participants as per information on clinitcaltrials.gov. This research endeavour was initially posted in November of 2019 and underwent its latest modification on March 25th 2022.

Q: Does this research initiative include participants over the age of fifty?

Those desiring to take part in this trial must be between 30 and 60 years old. For those younger than 18, there are 19 studies available; for individuals older than 65, 153 research initiatives exist.

Phase < 1

Recruiting

Led By Clayton Commander, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 30 and 60 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 240 hours

Awards & highlights

Study Summary

This trial is testing whether adding a corticosteroid to a nerve block improves pain relief and reduces narcotic use for women undergoing a uterine artery embolization.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site like pain or infection, steroid-related issues such as increased blood sugar levels (not relevant here due to diabetes exclusion), and potential nerve damage from the block procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 30 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 240 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 240 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 240 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain Intensity Measure (mm)

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Triamcinolone

2016

Completed Phase 4

~1220

Bupivacaine

2013

Completed Phase 4

~1530

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,191,014 Total Patients Enrolled

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,240 Total Patients Enrolled

1 Trials studying Adenomyosis

40 Patients Enrolled for Adenomyosis

Clayton Commander, MDPrincipal InvestigatorUniversity of North Carolina

1 Previous Clinical Trials

12 Total Patients Enrolled

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04126824 — Phase < 1

Adenomyosis Research Study Groups: Bupivacaine and Triamcinolone, Bupivacaine

Adenomyosis Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT04126824 — Phase < 1

Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04126824 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I be accepted as a participant in this medical research?

"This clinical trial seeks 28 patients that are between the ages of 30 and 60 with a diagnosis of adenomyosis."

Answered by AI

What medical conditions have been known to respond positively to Triamcinolone treatment?

"Typically, Triamcinolone is administered to address permphigus. However, this drug has also been found successful in treating lupus erythematosus cell, ulcerative colitis and hand-related conditions."

Answered by AI

How many individuals have enrolled in the clinical trial thus far?

"Affirmative, the details present on clinicaltrials.gov verify that this trial is actively enrolling individuals. First posted in November 5th 2019 and most recently edited March 25th 2022, it is looking for 28 test subjects from a single site."

Answered by AI

Is there still an opportunity to be part of this research endeavor?

"Affirmative, the clinical trial is still recruiting participants as per information on clinitcaltrials.gov. This research endeavour was initially posted in November of 2019 and underwent its latest modification on March 25th 2022."

Answered by AI

Does this research initiative include participants over the age of fifty?

"Those desiring to take part in this trial must be between 30 and 60 years old. For those younger than 18, there are 19 studies available; for individuals older than 65, 153 research initiatives exist."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Addition of Steroids on Duration of Analgesia

Jessica K. Stewart, MD 2019. "Effect of Addition of Steroids on Duration of Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04126824.

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