80 Participants Needed

QL Block for Postoperative Pain in Fibroid Surgery

CP
Overseen ByCatherine P Haering, BA
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Joseph Findley MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a QL block, an anesthetic injection in a lower back muscle, can effectively reduce pain after surgery to remove uterine fibroids. Participants will be randomly assigned to receive either a real QL block or a sham injection, along with standard pain care. The goal is to determine if the QL block provides better pain relief compared to not receiving it. Individuals with uterine fibroids who require surgery to remove them, while keeping the uterus intact, may be suitable for this trial. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you use chronic opioids, you may not be eligible to participate.

What is the safety track record for the QL Block?

Research shows that the quadratus lumborum (QL) block is safe and well-tolerated for managing post-surgical pain. Studies have found it provides effective pain relief for several hours after a procedure. Importantly, compared to other pain management methods like bupivacaine infiltration, the QL block reduces pain more effectively.

Further evidence suggests that QL blocks are safe and can decrease the need for opioids, which often cause side effects. In surgeries such as hernia and abdominal procedures, QL blocks have proven both safe and effective. As this technique becomes a standard part of anesthesia care, its safety remains well-recognized.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for postoperative pain management in fibroid surgery, which often relies on oral medications like opioids or NSAIDs, the QL Block offers a targeted approach. This technique involves injecting Bupivacaine directly into the quadratus lumborum muscle, which may provide more localized and effective pain relief. Researchers are excited because this method could minimize the need for systemic pain medications, potentially leading to fewer side effects and a faster recovery.

What evidence suggests that the QL block is effective for reducing postoperative pain in fibroid surgery?

Research has shown that the quadratus lumborum (QL) block can greatly reduce post-surgery pain. Studies found that patients who received a QL block experienced less pain than those who did not. This method is particularly beneficial for surgeries in the lower abdomen and pelvis, such as uterine fibroid removal. In this trial, one group of participants will receive a QL block with Bupivacaine, which may provide better pain relief than other methods, like injecting pain medicine directly into the surgical area. Patients required less pain medication after receiving a QL block. This evidence supports the QL block as an effective way to manage pain after fibroid surgery.26789

Who Is on the Research Team?

JF

Joseph Findley, MD

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing and able to follow all study rules and be available for its duration.
I need surgery for uterine fibroids but want to keep my uterus.
Provision of signed and dated informed consent form

Exclusion Criteria

I have a blood clotting disorder.
I have been diagnosed with anxiety or depression.
Illiteracy due to inability to read and understand plain questionnaire
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 a myomectomy procedure with or without a QL block for postoperative pain management

1 week
1 visit (in-person)

Follow-up

Participants are monitored for pain levels and satisfaction with pain management up to 48 hours after discharge

1 week
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • QL Block
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: QL Block with BupivacaineExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joseph Findley MD

Lead Sponsor

Trials
1
Recruited
80+

Published Research Related to This Trial

The quadratus lumborum (QL) block is an effective postoperative analgesic technique for major laparotomy, resulting in low pain scores and reduced opioid consumption on the first day after surgery.
This method provides sensory block up to the T8-L1 levels, indicating its potential for effective pain management in abdominal surgeries.
Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy.Kadam, VR.[2022]
In a study of 60 female patients undergoing total abdominal hysterectomy, bilateral quadratus lumborum (QL) block resulted in significantly lower consumption of opioids (fentanyl and morphine) compared to bilateral transverse abdominis plane (TAP) block.
Patients receiving the QL block reported lower pain scores at all postoperative time points and experienced a longer duration of analgesia, indicating that QL block is more effective for pain management after this type of surgery.
Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial.Yousef, NK.[2022]
Bilateral quadratus lumborum (QL) block provided significant pain relief for a 43-year-old woman after uterine artery embolization, reducing her pain score from 8/10 to 3/10 within an hour and maintaining low pain levels (2-3/10) for 24 hours without the need for additional analgesics.
The study suggests that QL block could be a highly effective alternative for managing acute postoperative pain after uterine artery embolization, potentially reducing reliance on opioids and improving patient comfort.
Quadratus lumborum block in management of severe pain after uterine artery embolization.Ben-David, B., Kaligozhin, Z., Viderman, D.[2019]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40454255/
Enhanced Postoperative Pain Management: A ...The QL block proved more effective than intraperitoneal and periportal bupivacaine infiltration in reducing postoperative pain scores for 6 hours.
Efficacy of bilateral quadratus lumborum block with ...This study aims to evaluate whether bilateral QL blocks with liposomal bupivacaine can optimize postoperative pain management while reducing analgesic ...
Efficacy of quadratus lumborum block in the treatment of...The results showed that the QLB group could significantly reduce the VAS score 24 hours after the operation as compared with the control group ( ...
Postoperative Analgesic Effects of Quadratus Lumborum ...It has been shown to be effective in adult patients undergoing lower abdominal surgery, offering improved postoperative pain scores and reduced ...
Anesthesiology and Pain MedicineThis study demonstrated that the QL block is more successful in providing prolonged and efficient analgesia, as indicated by reduced VAS scores, accompanied by ...
Efficacy of bilateral quadratus lumborum block with ...Additionally, existing evidence indicates that bilateral quadratus lumborum (QL) blocks provide more effective postoperative pain relief than ...
Postoperative Pain - NCT05979493 - Joseph Findley MDThis study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine ...
Posterior Quadratus Lumborum Block Versus ...The study results showed that both posterior QLB and TAPB provided a safe and effective postoperative analgesia after inguinal hernia surgery.
(PDF) Ultrasound-guided quadratus lumborum blockQL block provides effective pain management after abdominal surgery; helps reduce the need for opioids, which can have side effects ...
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