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QL Block for Postoperative Pain in Fibroid Surgery
Phase 4
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours after discharge from hospital.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I need surgery for uterine fibroids but want to keep my uterus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 hours after discharge from hospital.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours after discharge from hospital.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time in minutes from first analgesic request as measured by medical chart review
Total number of doses of rescue analgesics given as measured by medical chart review
Secondary outcome measures
Pain as measured by visual analog scale (VAS)
Patient satisfaction with perioperative pain management measured on a scale of 1-10
Other outcome measures
Pain as measured by Richmond Agitation Sedation Scale (RASS)
Side effects data
From 2009 Phase 4 trial • 180 Patients • NCT0052733213%
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
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
~1610
Find a Location
Who is running the clinical trial?
Joseph Findley MDLead Sponsor
Joseph Findley, MDPrincipal InvestigatorUniversity Hospitals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with anxiety or depression.I am willing and able to follow all study rules and be available for its duration.I have a blood clotting disorder.I have long-term nerve or pelvic pain.I need surgery for uterine fibroids but want to keep my uterus.You have been using opioid pain medications for a long time.You have a body mass index (BMI) higher than 38.I do not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: QL Block with Bupivacaine
- Group 2: Control
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants of this research program restricted to adults?
"This trial is pinned to a recruitment of patients between the ages 18 and 45. For younger participants, there are 76 prominent studies available while 441 exist for senior citizens."
Answered by AI
Are there any opportunities for volunteers to participate in this experiment?
"The clinicaltrials.gov website reflects that this medical trial is no longer actively enrolling participants. First posted on September 1st 2023, the study was last updated on July 28th 23rd and has since ceased from collecting patients into its program. On a brighter note, there are still 579 other studies in search of candidates at present time."
Answered by AI
For whom is this experiment suitable?
"The requirements for participation in this trial are ages 18-45 and a diagnosis of postoperative pain. 80 candidates are being sought out to participate."
Answered by AI
Has the FDA sanctioned QL Block with Bupivacaine?
"With QL Block and Bupivacaine, our team judged it to be a 3 on the safety scale due to its current Phase 4 status, indicating that this therapy has been officially approved."
Answered by AI
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