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

Trial Summary

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.

Is the rectus sheath block safe for use in humans?

The rectus sheath block (RSB) is generally considered safe, especially when guided by ultrasound, as shown in a study involving 4,033 patients that looked at complications and technical considerations to minimize risks. ^{1 2 3 4 5}

How is the rectus sheath block treatment different from other treatments for gynecologic surgery?

Rectus sheath block (RSB) is unique because it is a regional anesthesia technique that specifically targets the anterior abdominal wall to reduce pain after surgery, unlike systemic pain medications that affect the whole body. It can be guided by ultrasound for precision, and it helps decrease the need for opioids, which are strong painkillers with potential side effects. ^{1 2 6 7 8}

What is the purpose of this trial?

Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.

Research Team

Ashraf Habib, M.D.

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Ultrasound-guided bilateral rectus sheath block reduces early postoperative pain after laparoscopic gynecologic surgery: a randomized study. [2019]

2. England 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. [2021]

3. Romania pubmed.ncbi.nlm.nih.gov

Rectus Sheath Block in Abdominal Surgery: A Systematic Review with Meta-Analysis. [2023]

4. United States 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. [2022]

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

Complications and Technical Consideration of Ultrasound-Guided Rectus Sheath Blocks: A Retrospective Analysis of 4033 Patients. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

The surgical rectus sheath block for post-operative analgesia: a modern approach to an established technique. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

A new neurostimulator guided technique of rectus sheath block: study of feasibility and local anesthetic spread in children. [2020]

8. England 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. [2021]