Rectus Sheath Block for Gynecologic Surgery

Overseen By Ashraf Habib, MBBCh, MSc, MHSc, FRCA

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Duke University

Must not be taking: Opioids, NSAIDs

Disqualifiers: BMI >50, Chronic pain, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to pain control after gynecologic cancer surgery. It focuses on using a rectus sheath block, which involves injecting pain relief medication near the abdominal muscles, to determine if it is more effective than the traditional thoracic epidural method. The trial targets individuals who have undergone surgery for gynecologic cancer with a vertical incision. Participants should not have a BMI over 50, chronic pain, or allergies to the pain medications used in the trial. The goal is to find a more effective way to manage post-surgery pain. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic pain or opioid therapy, you would not be eligible to participate.

What is the safety track record for the Rectus Sheath Block treatment?

Research has shown that the rectus sheath block (RSB) is generally safe and well-tolerated. Studies have found that this treatment effectively reduces post-surgery pain without causing major side effects. Patients often experience better pain control for up to 12 hours after surgery and require fewer painkillers.

One study found that RSB can be safely used even in patients with higher body weight, with no significant reports of negative effects. This makes it a promising option for managing pain after abdominal surgeries.

This trial uses a combination of two anesthetics: liposomal bupivacaine and regular bupivacaine. Liposomal bupivacaine has already been approved for other uses, providing some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Rectus Sheath Block for gynecologic surgery because it offers a targeted pain relief option that might be more effective and have fewer side effects than the traditional thoracic epidural analgesia. Unlike epidurals, which involve injecting anesthetic near the spinal cord, the rectus sheath block uses ultrasound guidance to deliver anesthesia directly around the abdominal muscles, potentially resulting in more precise pain control. This method utilizes liposomal bupivacaine, a longer-lasting form of bupivacaine, which may provide extended pain relief with a single injection. These features could lead to faster recovery times and shorter hospital stays for patients undergoing surgery.

What evidence suggests that the Rectus Sheath Block might be an effective treatment for gynecologic surgery?

This trial will compare the effectiveness of Rectus Sheath Blocks (RSBs) with Thoracic Epidural Analgesia for managing pain after gynecologic surgery. Research has shown that RSBs can effectively manage postoperative pain. One study found that RSBs significantly reduced early pain in children after laparoscopic surgery. Another study demonstrated that patients receiving an RSB experienced less pain upon waking and required less morphine afterward. Additionally, RSBs have improved recovery in patients undergoing open gynecological surgery, providing better pain control without additional side effects. Overall, RSBs appear promising for reducing postoperative pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Ashraf Habib, M.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18 or older who are undergoing a laparotomy with a vertical incision for gynecologic cancer and have an ASA classification of II or III, indicating they have mild to severe systemic disease but are not at extreme risk.

Inclusion Criteria

I am over 18 and will have surgery for a gynecologic cancer with a vertical cut.

I have a mild to severe systemic disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for pain intensity and complications related to the rectus sheath block or epidural analgesia

72 hours

Continuous monitoring during hospital stay

Long-term follow-up

Participants are monitored for any long-term complications or outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rectus Sheath Block

Trial Overview The study tests pain control methods after gynecological surgery. It compares the effectiveness of rectus sheath block using liposomal bupivacaine and regular bupivacaine against traditional thoracic epidural analgesia in matched patient groups.

How Is the Trial Designed?

Group I: Rectus Sheath Block Group (Prospective arm) Experimental Treatment 3 Interventions

Thirty subjects will be prospectively enrolled and will receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.

Group II: Thoracic Epidural Analgesia Group (retrospective arm) Active Control 2 Interventions

60 patients who received thoracic epidural analgesia as part of our enhanced recovery after surgery protocol and stayed in hospital for at least 72 h.

Rectus Sheath Block is already approved in United States, European Union for the following indications:

Approved in United States as Rectus Sheath Block for:

• Postoperative analgesia for gynecological laparotomy
• Postoperative pain relief for midline abdominal surgeries

Approved in European Union as Rectus Sheath Block for:

• Postoperative analgesia for gynecological laparotomy
• Postoperative pain relief for midline abdominal surgeries

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The surgical rectus sheath block significantly reduced post-operative pain scores and morphine consumption compared to standard subcutaneous local anaesthetic in 98 patients undergoing major gynaecological surgery.

Patients receiving the rectus sheath block also had shorter recovery times, with earlier discontinuation of patient-controlled analgesia and a reduced length of hospital stay, indicating its potential for improved post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The surgical rectus sheath block for post-operative analgesia: a modern approach to an established technique. Crosbie, EJ., Massiah, NS., Achiampong, JY., et al.[2022]

Ultrasound-guided bilateral rectus sheath block (US-BRSB) significantly reduces immediate postoperative pain in patients undergoing laparoscopic gynecologic surgery, as evidenced by lower pain scores compared to the control group at multiple time points.

Patients receiving US-BRSB required significantly less fentanyl as rescue analgesics in the postoperative period, indicating reduced opioid consumption and potentially improved pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided bilateral rectus sheath block reduces early postoperative pain after laparoscopic gynecologic surgery: a randomized study. Cho, S., Kim, YJ., Jeong, K., et al.[2019]

This study will compare the effectiveness of preoperative versus postoperative rectus sheath block (RSB) in managing postoperative pain and sleep quality in 64 patients undergoing gynaecological surgery, with the primary focus on the timing of the first pain relief after surgery.

The trial aims to determine if preoperative RSB provides longer-lasting pain relief compared to postoperative RSB, which could lead to improved pain management strategies and potentially shorter hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels of patients with open midline incisions undergoing transabdominal gynaecological operation: study protocol for a randomised controlled trial. Jin, F., Li, XQ., Tan, WF., et al.[2021]

Bilateral rectus sheath block (BRSB) significantly improved postoperative outcomes in patients undergoing cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC), including shorter tracheal extubation time and reduced opioid consumption.

BRSB also led to lower pain scores and fewer postoperative complications, such as hypertension and nausea, demonstrating its effectiveness and safety as an analgesic technique in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of ultrasound-guided bilateral rectus sheath block in patients undergoing cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy - a retrospective study. Wang, S., Liu, P., Gao, T., et al.[2021]

In a study of 4033 patients undergoing ultrasound-guided rectus sheath blocks (RSBs) for laparoscopic surgery, the overall complication rate was low at 2.4%, with the most common issue being extrarectus sheath injections (2.2%).

Vascular injuries were rare, occurring in only 0.2% of cases, and all resulted in hematomas, indicating that while RSBs are generally safe, careful technique is essential to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and Technical Consideration of Ultrasound-Guided Rectus Sheath Blocks: A Retrospective Analysis of 4033 Patients. Kwon, HJ., Kim, YJ., Kim, Y., et al.[2023]

Neurostimulator (NS) guided rectus sheath block (RSB) is a feasible technique for providing abdominal wall analgesia, especially in settings without ultrasound equipment, with a high clinical efficacy observed in all cases.

In a study involving patients receiving NS guided RSB, optimal local anesthetic spread was achieved in 74.14% of cases, demonstrating that this method can effectively manage pain during surgical procedures without the need for additional opioid administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new neurostimulator guided technique of rectus sheath block: study of feasibility and local anesthetic spread in children. Albokrinov, AA., Perova-Sharonova, VM., Fesenko, UA.[2020]

In a study of 57 patients undergoing midline laparotomy, the repeated-doses method of rectus sheath block (RSB) provided better pain relief and increased patient satisfaction compared to a control group, especially during the first 48 hours post-surgery.

The repeated-doses RSB also resulted in lower opioid consumption, indicating its potential as an effective analgesic strategy that reduces the need for opioids without causing serious adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized, open label, controlled study investigating the efficiency and safety of 3 different methods of rectus sheath block analgesia following midline laparotomy. Purdy, M., Kinnunen, M., Kokki, M., et al.[2022]

A systematic review of eight randomized controlled trials involving 386 patients found that rectus sheath block (RSB) did not significantly reduce postoperative pain intensity or opioid consumption compared to control groups after abdominal surgery.

The study concluded that RSB does not provide a clear advantage over non-RSB methods in terms of pain management or reducing the need for analgesics post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rectus Sheath Block in Abdominal Surgery: A Systematic Review with Meta-Analysis. Abdildin, Y., Tapinova, K., Salamat, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10903772/

Investigation into the clinical performance of rectus sheath ... This systematic review evaluated the efficacy and outcome data of patients undergoing RSB compared to the standard of care in both laparoscopic ...

2. journals.lww.com journals.lww.com/md-journal/fulltext/2024/10250/the_analgesic_benefit_of_rectus_sheath_block_in.99.aspx

The analgesic benefit of rectus sheath block in robotic... The study found that RSB significantly reduced early postoperative pain in children undergoing laparoscopic appendicectomy. These studies ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030121151100618X

The surgical rectus sheath block for post-operative analgesia Patients who received the surgical rectus sheath block had lower pain scores on waking [0 (0–1) vs. 2 (1–3), p < 0.001], required less morphine post-operatively ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11194829/

Effect of Rectus Sheath Block on Postoperative Quality ... Rectus sheath block improves the quality of recovery in patients undergoing open gynecological surgery one day after surgery without adverse effects.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02476799

Analgesic Effects of US Bilateral Rectus Sheath Block for ... The purpose of this study is to investigate the analgesic effect of ultrasound-guided RSB to multi-port laparoscopic gynecologic surgery which has incision site ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480420308556

Efficacy and Safety Profile of Rectus Sheath Block in Adult ... RSB improves pain control for up to 12 h postoperatively and reduces opioid consumption, without major reported adverse events.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02450084

Ultrasound-guided Bilateral Rectus Sheath Block for ... The purpose of this study is to investigate the analgesic effect of ultrasound-guided RSB to single-port robotic gynecologic surgery which has incision site at ...

8. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(20)30855-6/abstract

Efficacy and Safety Profile of Rectus Sheath Block in Adult ... RSB improves pain control for up to 12 h postoperatively and reduces opioid consumption, without major reported adverse events.