Quadratus Lumborum Block for Postoperative Pain

Overseen By Candice E Jones-Cox, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Walter Reed National Military Medical Center

Must not be taking: Opioids

Disqualifiers: Opioid use, Pain clinic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

76 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if preoperative nerve block (quadratus lumborum \[QL\] block) works to improve pain control during and after laparoscopic hysterectomy. The main questions it aims to answer are: Does QL block decrease the amount of narcotic medication needed during surgery? Does QL block decrease the amount of narcotic medication needed after surgery? Researchers will compare QL block to local injection of a numbing medication at each incision site (the current standard practice) to see if QL block works to decrease surgical pain. Participants will be randomly assigned to receive one of the two following interventions: 1. QL block before surgery with a long-acting numbing medicine (liposomal bupivacaine) and then injection of placebo (saline) at each incision site in the operating room. 2. QL block before surgery with placebo (saline) and then injection of local numbing medicine (bupivacaine) at each incision site in the operating room. Participants will also: * Visit the clinic/hospital for a pre-operative appointment, the surgical procedure, and a 4-6 week post-operative appointment (all standard visits even if not participating in research) * Complete a questionnaire electronically, or by phone, that takes \<10 minutes at the pre-operative appointment and on postoperative days 1, 3, 5, 14, and 4-6 weeks.

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 data supports the effectiveness of the treatment Quadratus Lumborum Block for postoperative pain?

Research shows that the Quadratus Lumborum Block (a type of pain relief technique) is effective in reducing pain and the need for opioids (strong painkillers) after various surgeries, including abdominal and hip surgeries. Studies have found that it provides good pain control and helps patients recover faster by allowing them to move around sooner after surgery. ^{1 2 3 4 5}

Is the quadratus lumborum block generally safe for humans?

The quadratus lumborum block (QL block) has been used safely in various surgeries, including abdominal and spinal procedures, and in both adults and children. While the safety can vary depending on the specific approach used, studies generally support its safe use for managing postoperative pain. ^{2 6 7 8 9}

How is the Quadratus Lumborum Block treatment different from other treatments for postoperative pain?

The Quadratus Lumborum Block (QL Block) is unique because it is a type of nerve block that targets the quadratus lumborum muscle in the lower back, providing pain relief by blocking nerve signals in a specific area. Unlike systemic pain medications, it offers localized pain control, which can reduce the need for opioids and their side effects. It is administered using ultrasound guidance, which helps ensure precise delivery of the anesthetic. ^{3 4 5 7 8}

Research Team

Kathryn A Edmonds, MD

Principal Investigator

Walter Reed National Military Medical Center

Eligibility Criteria

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)

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo Experimental Treatment 2 Interventions

Subjects will receive a pre-operative quadratus lumborum nerve block with liposomal bupivacaine and then an intra-operative placebo injection at each incision site with saline.

Group II: Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine Active Control 2 Interventions

Subjects will undergo a sham pre-operative quadratus lumborum block procedure with saline and then an intra-operative injection of local anesthetic (0.25% bupivacaine) at each incision site.

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Findings from Research

The posterior quadratus lumborum block (QLB2) significantly reduces pain scores at 6, 12, and 24 hours after abdominal surgery compared to control groups, based on a meta-analysis of 14 studies with 1001 patients.

QLB2 also decreases opioid consumption within the first 24 hours post-surgery, indicating its effectiveness in managing postoperative pain, especially for patients under general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Posterior Quadratus Lumborum Block for Acute Postoperative Analgesia in Adult Patients: A Meta-Analysis of Randomized Controlled Trials. Lin, C., Wang, X., Qin, C., et al.[2022]

The Quadratus lumborum (QL) block significantly reduces opioid requirements in patients undergoing cesarean deliveries and renal surgeries, based on a systematic review of 22 studies.

QL block may provide effective postoperative analgesia for up to 24 hours, although evidence for its effectiveness in other types of surgeries is limited and further studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single injection Quadratus Lumborum block for postoperative analgesia in adult surgical population: A systematic review and meta-analysis. Jin, Z., Liu, J., Li, R., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. Kadam, VR.[2022]

In a study of 60 patients undergoing lumbar disc herniation surgery, the quadratus lumborum block (QLB) significantly reduced postoperative pain scores at 0 and 2 hours compared to a control group, indicating its efficacy in pain management.

Patients receiving the QLB reported higher satisfaction and required less rescue analgesia, while also experiencing fewer instances of nausea, suggesting that QLB not only improves pain control but also enhances overall patient comfort after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasound-guided anterior quadratus lumborum block for pain management following lumbar spinal surgery: a randomized controlled trial. Alver, S., Bahadir, C., Tahta, AC., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quadratus lumborum block in management of severe pain after uterine artery embolization. Ben-David, B., Kaligozhin, Z., Viderman, D.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block for postoperative pain control in patients undergoing unilateral inguinal hernia repair, a comparative study between two approaches. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Posterior Quadratus Lumborum Block for Acute Postoperative Analgesia in Adult Patients: A Meta-Analysis of Randomized Controlled Trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Single injection Quadratus Lumborum block for postoperative analgesia in adult surgical population: A systematic review and meta-analysis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Postoperative analgesic effectiveness of quadratus lumborum block: systematic review and meta-analysis for adult patients undergoing hip surgery. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block in pediatrics: trans-muscular versus intra-muscular approach. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasound-guided anterior quadratus lumborum block for pain management following lumbar spinal surgery: a randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Quadratus lumborum block in management of severe pain after uterine artery embolization. [2019]

9. Nepal pubmed.ncbi.nlm.nih.gov

USG Guided Quadaratus Lumburoum Block and Low Dose Spinal Anesthesia in Abdominal Surgeries. [2021]