Quadratus Lumborum Block for Postoperative Pain

KA
CE
Overseen ByCandice E Jones-Cox, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Walter Reed National Military Medical Center
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 aims to determine if a preoperative quadratus lumborum block (a nerve block that numbs specific muscles) can better control pain during and after a laparoscopic hysterectomy. Researchers seek to find out if this method reduces the need for narcotic medication compared to the standard practice of local numbing injections at the incision sites. Participants will be randomly assigned to receive either the nerve block with a placebo at incision sites or a placebo nerve block with standard numbing injections. This trial may suit individuals scheduled for a laparoscopic hysterectomy who do not use opioids before surgery and can complete follow-up questionnaires online or via text. As a Phase 4 trial, this research helps to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use opioids before surgery or if you cannot take certain pain medications like bupivacaine, NSAIDs, acetaminophen, or oxycodone.

What is the safety track record for the Quadratus Lumborum Block?

Research has shown that the quadratus lumborum (QL) block with liposomal bupivacaine is generally well-tolerated. Studies have found that this method provides effective and long-lasting pain relief, often reducing the need for opioids after surgery. This approach manages pain effectively without causing major side effects.

For gynecologic surgeries, QL blocks have successfully controlled post-operative pain. Specifically, using liposomal bupivacaine in these blocks has decreased the amount of pain medication needed after surgery. This is encouraging for those who want to limit opioid use while still managing pain effectively.

These studies have reported no serious side effects related to the QL block with liposomal bupivacaine, offering reassurance about its safety for those considering this pain management option during surgery.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Quadratus Lumborum Block for postoperative pain because it may offer a more effective way to manage pain after surgery. Unlike standard treatments that often involve systemic opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), this approach uses a targeted nerve block with liposomal bupivacaine, which could provide longer-lasting pain relief with fewer side effects. The use of liposomal bupivacaine allows for a slow and sustained release of the anesthetic, potentially reducing the need for additional pain medications and enhancing patient recovery. By directly targeting the nerves near the surgical site, this method aims to improve pain management while minimizing the systemic impact, making it a promising alternative to current pain relief options.

What evidence suggests that the Quadratus Lumborum Block is effective for postoperative pain control during and after laparoscopic hysterectomy?

Research has shown that the quadratus lumborum (QL) block effectively reduces pain after surgery. Studies have found that this nerve block decreases the need for opioid painkillers after surgeries such as hip operations and cesarean sections. In one study, patients who received the QL block reported less pain both at rest and during movement. Another study on laparoscopic hysterectomy found that the QL block reduced opioid use and postoperative pain. In this trial, one group of participants will receive a preoperative QL block with liposomal bupivacaine, which could offer better pain control after surgery. Another group will receive a sham preoperative QL block with a placebo and an intra-operative injection with bupivacaine.56789

Who Is on the Research Team?

KA

Kathryn A Edmonds, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for laparoscopic hysterectomy who are interested in better pain control. Participants must attend standard pre-operative and post-operative appointments, as well as complete short questionnaires on their pain levels at specified times after surgery.

Inclusion Criteria

Able to speak and understand English
Owning a phone that can receive text messages or having internet access to complete questionnaires
DEERs eligible (eligible for healthcare within military health system)
See 1 more

Exclusion Criteria

I cannot take oxycodone.
My surgery was changed to an open procedure.
I cannot have a QL block done on both sides of my body.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preoperative

Participants receive a preoperative quadratus lumborum block or placebo before surgery

1 day
1 visit (in-person)

Intraoperative

Participants undergo laparoscopic hysterectomy with either QL block or local anesthetic at incision sites

1 day
1 visit (in-person)

Immediate Postoperative

Participants are monitored for opioid use and pain scores in the PACU

1 day
1 visit (in-person)

Follow-up

Participants are monitored for opioid use, pain scores, and quality of recovery at various postoperative days

4-6 weeks
Multiple visits (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

  • Quadratus Lumborum Block
Trial Overview The study tests if a QL block with liposomal bupivacaine before surgery reduces the need for narcotic medication during and after the procedure compared to just local numbing at incision sites. Patients will be randomly assigned to receive either the QL block or placebo plus local anesthetic.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placeboExperimental Treatment2 Interventions
Group II: Preoperative QL block with placebo, intra-operative incisional injection with bupivacaineActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials
149
Recruited
33,800+

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]
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]
The quadratus lumborum (QL) block significantly reduces opioid consumption by approximately 15.78 mg in the first 24 hours after hip surgery compared to placebo or no block, indicating its efficacy in postoperative pain management.
Patients receiving the QL block reported a reduction in pain during movement, with a pain grade decrease of 2.95 compared to those who did not receive the block, suggesting improved analgesia without affecting static pain scores.
Postoperative analgesic effectiveness of quadratus lumborum block: systematic review and meta-analysis for adult patients undergoing hip surgery.Xiong, H., Chen, X., Zhu, W., et al.[2022]

Citations

Postoperative analgesic effectiveness of quadratus ...Our meta-analysis indicates that QL block may be effective for analgesia in patients after hip surgery compared with placebo or no block.
Efficacy of Quadratus Lumborum Block for Postoperative ...This study aimed to evaluate whether QLB reduces opioid consumption and postoperative pain in patients undergoing single-port TLH.
Postoperative analgesic effects of the quadratus lumborum ...Background: This study assessed the postoperative analgesic efficacy and safety of the quadratus lumborum block (QLB) in pediatric patients.
Quadratus lumborum block for postoperative analgesia ...QLB improves post-cesarean delivery analgesia in parturients not receiving neuraxial morphine. Addition of QLB to parturients receiving neuraxial morphine has ...
The efficacy of combined lateral and anterior quadratus ...Additionally, patients who received QLB demonstrated significantly reduced levels of postoperative pain intensity both at rest and during ...
Efficacy of bilateral quadratus lumborum block with ...This randomized controlled trial aims to provide high-quality evidence on the efficacy and safety of liposomal bupivacaine QL blocks for post- ...
Liposomal Bupivacaine in Single‐Injection Quadratus ...A quadratus lumborum block with liposomal bupivacaine provided effective and sustained pain relief for our pediatric patient undergoing kidney transplant.
Liposomal Bupivacaine for Quadratus Lumborum Block at the ...The findings demonstrated that administration of liposomal bupivacaine in QLB-LASL significantly reduced postoperative opioid consumption while ...
Use of quadratus lumborum block in gynecologic proceduresQL blocks have been shown to be effective in managing post-operative pain after gynecologic surgical procedures.
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