QL Block + ERAS Protocol for Postoperative Pain

Overseen By Katelyn Donaldson, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-English fluency

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

Compensation: Varies

Number of Visits: 2

70 Participants Needed

Trial Summary

What is the purpose of this trial?

In the effort to reduce postoperative opioid use, there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process. Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery (ERAS) protocol and the use of peripheral and truncal nerve blocks. Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care. The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum (QL) nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy. Subjects will be randomized to the ERAS protocol or the QL block. The main questions the study aims to answer are: 1) does the QL block decrease patient reported pain scores postoperatively; and 2) does the QL block decrease the amount of opioid pain medications in the immediate postoperative period? The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit (PACU) following surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment QL Block + ERAS Protocol for Postoperative Pain?

Research shows that the quadratus lumborum (QL) block, a pain relief technique, effectively reduces pain and the need for opioids (strong painkillers) after various surgeries, including abdominal and hip surgeries. This suggests that using QL block as part of the Enhanced Recovery After Surgery (ERAS) protocol could help manage postoperative pain effectively. ^{1 2 3 4 5}

Is the QL Block + ERAS Protocol safe for humans?

The Quadratus Lumborum (QL) block has been used safely for managing pain after various surgeries, including abdominal, hip, and spinal surgeries, with no major safety concerns reported in the studies. ^{2 3 4 6 7}

How is the QL Block + ERAS Protocol treatment different from other treatments for postoperative pain?

The QL Block is a unique regional pain relief technique that targets the quadratus lumborum muscle in the lower back, providing effective pain control after surgeries, especially abdominal and hip surgeries. Unlike systemic pain medications, it offers localized pain relief, potentially reducing the need for opioids and their side effects. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for English-speaking women aged 18 or older who are undergoing robotic-assisted surgery for pelvic organ prolapse, with or without concurrent hysterectomy. Participants must be able to consent.

Inclusion Criteria

I can read, write, and speak English fluently.

I am able to understand and agree to the study's procedures and risks.

I am having or have had a robotic surgery for pelvic organ prolapse, with or without hysterectomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Participants receive either the QL block or follow the ERAS protocol prior to surgery

1 day

1 visit (in-person)

Immediate Postoperative

Participants are monitored in the PACU for pain scores, opioid requirements, and other postoperative outcomes

Immediate postoperative period

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enhanced Recovery After Surgical (ERAS) Protocol
• Quadratus Lumborum (QL) Block

Trial Overview The study compares two pain management methods after pelvic surgery: the standard Enhanced Recovery After Surgery (ERAS) protocol and a nerve block technique called Quadratus Lumborum (QL) Block. It aims to see if QL reduces pain and opioid use post-surgery.

Participant Groups

Group I: Quadratus Lumborum Block Active Control 1 Intervention

The QL block will be performed by the regional anesthesia team according to their standard protocol with a uniform quantity and concentration of analgesic agent (ropivacaine 60cc). Intraoperatively, patients will undergo subcutaneous injections of lidocaine (2cc per port site) at each port site. Preoperatively, patients will only receive acetaminophen and no preoperative narcotics or neuro-modulators will be administered. Intraabdominal pressure intraoperative will be standardized among surgeons (plan for 15mm Hg for port placement, then 12 mm Hg once docked). At the conclusion of each surgery, eligible patients will receive a dose of IV ketorolac. Postoperatively, patients will be prescribed a standard regimen of NSAIDs, acetaminophen and opioids. Patients will be asked to rate their pain according to the numeric pain rating scale immediately postoperatively in the PACU and patient opioid requirements while in the PACU will be reviewed in the chart.

Group II: Enhanced Recovery After Surgery (ERAS) Protocol Active Control 1 Intervention

The ERAS protocol is a multimodal approach to pain control while minimizing opioid medications. Subjects randomized to the ERAS arm will undergo the standard ERAS protocol of early postoperative ambulation, no bowel preparation, and the use of multimodal pain medications including acetaminophen and non-steroid anti-inflammatory drugs (NSAIDs). Intraabdominal pressure intraoperative will be standardized among surgeons (plan for 15mm Hg for port placement, then 12 mm Hg once docked). At the conclusion of each surgery, eligible patients will receive a dose of IV ketorolac. Postoperatively, patients will be prescribed a standard regimen of NSAIDs, acetaminophen and opioids. Patients will be asked to rate their pain according to the numeric pain rating scale immediately postoperatively in the PACU and patient opioid requirements while in the PACU will be reviewed in the chart.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

The quadratus lumborum (QL) block significantly reduces pain scores at rest and with movement for up to 48 hours post-surgery, with the most notable improvement observed at 12 hours after surgery.

Patients receiving the QL block required additional analgesics much later than those in the control group, indicating its effectiveness as a multimodal analgesic approach for abdominal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of quadratus lumborum block for postoperative pain: a systematic review and meta-analysis. Kim, SH., Kim, HJ., Kim, N., et al.[2021]

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 80 patients undergoing total hip arthroplasty, the quadratus lumborum (QL) block significantly reduced pain scores and opioid consumption for up to 48 hours post-surgery compared to a control group without the block.

Patients receiving the QL block reported higher satisfaction scores, indicating that this technique not only provides effective pain relief but also enhances the overall patient experience after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior quadratus lumborum block analgesia for total hip arthroplasty: a randomized, controlled study. Kukreja, P., MacBeth, L., Sturdivant, A., et al.[2021]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Effectiveness of quadratus lumborum block for postoperative pain: a systematic review and meta-analysis. [2021]

2. India pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Anterior quadratus lumborum block analgesia for total hip arthroplasty: a randomized, controlled study. [2021]

4. 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]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

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

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]