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QL Block for Postoperative Pain in Fibroid Surgery

Phase 4
Recruiting
Led By Joseph Findley, MD
Research Sponsored by Joseph Findley MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of uterine fibroids requiring surgical excision with preservation of the uterus
Be between 18 and 65 years old
Must not have
Pre-existing diagnoses of anxiety or depression
Pre-existing coagulopathies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours after discharge from hospital.
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing if an injection in a lower back muscle can reduce postoperative pain for those undergoing a myomectomy. It will compare those given the injection with those who don't to see if it helps.

Who is the study for?
This trial is for individuals needing surgery to remove uterine fibroids who can follow the study's procedures and are available throughout the study. They must understand and sign a consent form. It excludes those with anxiety, depression, blood clotting issues, chronic pain or opioid use, non-English speakers, and those with a BMI over 38.
What is being tested?
The trial tests if a QL block—an anesthetic injection in the lower back—reduces post-surgery pain after myomectomy (fibroid removal). Participants will either receive this block along with standard care or just standard care alone. Assignment to these groups is random.
What are the potential side effects?
Possible side effects of the QL block may include temporary numbness or weakness in the lower back area, discomfort at injection site, allergic reactions to bupivacaine used in the block, and less commonly nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need surgery for uterine fibroids but want to keep my uterus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with anxiety or depression.
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I have a blood clotting disorder.
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I have long-term nerve or pelvic pain.
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I do not speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours after discharge from hospital.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours after discharge from hospital. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Pain as measured by visual analog scale (VAS)
Patient satisfaction with perioperative pain management measured on a scale of 1-10
Other study objectives
Pain as measured by Richmond Agitation Sedation Scale (RASS)

Side effects data

From 2009 Phase 4 trial • 180 Patients • NCT00527332
13%
Abdominal wound complication
8%
Infections
5%
Lower urinary tract infection
2%
Urinary bladder injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spinal Anesthesia
General Anesthesia

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: QL Block with BupivacaineExperimental Treatment1 Intervention
Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).
Group II: ControlPlacebo Group1 Intervention
Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacain
2022
Completed Phase 4
~1640

Find a Location

Who is running the clinical trial?

Joseph Findley MDLead Sponsor
Joseph Findley, MDPrincipal InvestigatorUniversity Hospitals

Media Library

QL Block with Bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT05979493 — Phase 4
Postoperative Pain Research Study Groups: QL Block with Bupivacaine, Control
Postoperative Pain Clinical Trial 2023: QL Block with Bupivacaine Highlights & Side Effects. Trial Name: NCT05979493 — Phase 4
QL Block with Bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05979493 — Phase 4
~53 spots leftby Jul 2025
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