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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for managing pain after surgery in women with pelvic organ prolapse. The goal is to determine if a nerve block, known as the quadratus lumborum (QL) block, reduces pain and opioid use more effectively than the standard Enhanced Recovery After Surgery (ERAS) protocol. Women undergoing robotic-assisted sacrocolpopexy surgery, who have had or will have a hysterectomy, are suitable candidates for this trial. Participants will either receive the QL block or follow the ERAS protocol to manage post-surgical pain. The study aims to identify which method reduces pain and opioid use more effectively immediately after surgery. As an unphased trial, it offers participants the chance to contribute to research that could enhance post-surgical pain management for future 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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the QL block and ERAS protocol are safe for managing postoperative pain?

Research has shown that the quadratus lumborum (QL) block is generally safe and well-tolerated. One study found it significantly reduced nausea after surgery, a common anesthesia side effect. Patients who received the QL block reported less pain 12 and 24 hours post-surgery compared to those who did not receive it. This suggests it effectively manages pain without major side effects.

For the Enhanced Recovery After Surgery (ERAS) protocol, studies have shown it is safe and effective. ERAS programs reduce the need for opioids after surgery, lowering the risk of side effects from these drugs. ERAS also improves recovery by encouraging early movement and using various methods to manage pain, making it a trusted approach in surgical care.

Both the QL block and ERAS protocols have demonstrated good safety records in previous research, making them promising options for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the QL Block and ERAS Protocol because they offer innovative approaches to managing postoperative pain. The QL Block is unique because it targets the quadratus lumborum muscle to deliver pain relief directly to the abdominal region, potentially reducing the need for opioids. This method uses ropivacaine, a local anesthetic, to provide targeted pain control. Meanwhile, the ERAS Protocol is a comprehensive strategy that focuses on minimizing opioid use by combining various pain management techniques, like early ambulation and the use of acetaminophen and NSAIDs. Both approaches aim to enhance recovery times and reduce reliance on opioids, addressing common concerns with traditional pain management.

What evidence suggests that this trial's treatments could be effective for managing postoperative pain?

In this trial, participants will join one of two treatment arms to manage postoperative pain. Research has shown that the quadratus lumborum (QL) block, which participants in one arm may receive, effectively reduces pain after surgery. Studies have found that it lowers pain levels and reduces the need for opioid painkillers during recovery. Specifically, patients who received the QL block after certain surgeries reported less pain and used fewer painkillers compared to those who did not receive the block.

Participants in the other arm will follow the Enhanced Recovery After Surgery (ERAS) protocol, known to improve pain management and reduce opioid use. This protocol combines different pain relief methods to help patients recover faster and with fewer complications. Evidence indicates that ERAS can lead to lower pain levels and a decrease in the need for opioids after surgery.

Both approaches in this trial aim to manage pain more effectively and reduce reliance on opioids, which can have negative side effects. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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.

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6395101/

Pain Management in Enhanced Recovery after Surgery ... Multimodal analgesia as part of an ERAS protocol improves postoperative pain control while reducing opiate use.

2. journals.lww.com journals.lww.com/clinicalpain/fulltext/2020/03000/enhanced_recovery_after_surgery__eras___a.11.aspx

Enhanced Recovery After Surgery (ERAS) Extensive evidence suggests that MMA regimens, implemented for postoperative pain management per ERAS protocols, are associated with a decrease in opioid dosing ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820097

Enhanced Recovery After Surgery Guidelines and Hospital ... ERAS guidelines provide recommendations for perioperative care and have been found to reduce complications, length of hospital stay, and cost.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6738505/

Evaluation of the effectiveness of an enhanced recovery after ... Implementation of ERAS was associated with an absolute reduction of 12% in postoperative complications and a significant reduction in surgical site infections ...

5. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/14/Suppl_3/A188.2

251 Analysis of the effectiveness of enhanced recovery ... Results Analysis revealed no significant difference in hospital length of stay between groups, with the ERAS group averaging 6.67 days (SD=0.75) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11962643/

Enhanced Recovery After Surgery (ERAS) Protocols in ... The results of this study showed that ERAS implementation significantly increased the relative rate of early ambulation (4.44; 95% CI, 3.19–6.21 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11127797/

Revitalizing Postoperative Pain Management in Enhanced ... This narrative review explores the crucial aspects of postoperative pain management within the framework of Enhanced Recovery After Surgery (ERAS).

8. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225006038

Optimising postoperative spine outcomes: an umbrella ... Specifically, ERASS protocols significantly shortened LOS by an average of 1.55 days and lowered postoperative complications by 39%. Opioid ...