Rectus Sheath Block for Postoperative Pain After Cardiac Surgery

Overseen By Himani Bhatt, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Opioids

Disqualifiers: Substance abuse, ASA class V, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate postoperative period

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block. 1. Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery? 2. Does the rectus sheath block decrease VAS pain scores postoperatively after cardiac surgery? Study participants will be assigned to receive either rectus sheath block or no block.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a history of substance abuse or chronic opioid use, you may not be eligible to participate.

What data supports the effectiveness of the treatment Rectus Sheath Block for postoperative pain after cardiac surgery?

Research shows that Rectus Sheath Block (RSB) is effective in reducing postoperative pain and the need for pain medication in surgeries involving the abdominal area, such as gynecological and cytoreductive surgeries. This suggests it may also help manage pain after cardiac surgery. ^{1 2 3 4 5}

Is rectus sheath block generally safe for humans?

Research shows that rectus sheath block (RSB) is generally considered safe, with a large study of 4033 patients indicating it is usually easy and safe when guided by ultrasound, though technical considerations are important to minimize complications. ^{1 2 4 6 7}

How does the rectus sheath block treatment differ from other treatments for postoperative pain after cardiac surgery?

The rectus sheath block (RSB) is unique because it is an anterior abdominal wall block that specifically targets the nerves in the abdominal area to reduce postoperative pain, potentially decreasing the need for opioids. Unlike systemic pain medications, RSB is administered locally, often guided by ultrasound, which can provide targeted pain relief with fewer side effects. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for adults aged 18-85 scheduled for cardiac surgery that involves chest tubes. It's not suitable for those with severe systemic disease (ASA class V), urgent surgeries, allergies to local anesthesia, inability to consent, or a history of substance abuse or chronic opioid use.

Inclusion Criteria

I am scheduled for a heart procedure that will use chest tubes.

I am either male or female.

Exclusion Criteria

I am unable or unwilling to give consent for treatment.

You are classified as ASA class V.

I need surgery urgently or as an emergency.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a rectus sheath block or no block during cardiac surgery

Immediate postoperative period

Postoperative Monitoring

Participants are monitored for opioid consumption, VAS pain scores, and time to extubation

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Rectus sheath block

Trial Overview The study is testing if a nerve block called Rectus Sheath Block can reduce pain and the need for opioids after heart surgery. Participants are randomly chosen to either receive this block or no block at all to compare outcomes.

Participant Groups

Group I: Rectus Sheath Block Experimental Treatment 1 Intervention

Group II: No block Active Control 1 Intervention

Rectus sheath block is already approved in European Union, United States for the following indications:

Approved in European Union as Rectus Sheath Block for:

• Mid-line abdominal incisions
• Umbilical hernia repair
• Paraumbilical hernia repair
• Epigastric hernia repair
• Pyloromyotomy
• Laparoscopic surgery
• Abdominoplasty
• Excision of urachal remnants
• Duodenal atresia repair

Approved in United States as Rectus Sheath Block for:

• Mid-line abdominal incisions
• Gynecologic abdominal surgeries
• Adult and pediatric umbilical herniorrhaphy
• Laparoscopic surgeries
• Emergency midline laparatomies

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

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]

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]

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 involving 10 patients undergoing cardiac surgery, the combination of pecto-intercostal fascial block (PIFB) and rectus sheath block (RSB) using 70 mL of 0.3% ropivacaine was found to be safe, with no patients reaching toxic levels of the drug (above 4.3 µg/mL).

The peak concentration of ropivacaine was observed between 10 and 30 minutes after administration, and there were no signs of systemic toxicity during the perioperative period, indicating that this analgesic protocol is effective and safe for managing pain in cardiac surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Total Ropivacaine Concentration in Blood after Bilateral Pecto-Intercostal Fascial Block Combined with Rectus Sheath Block in Cardiac Surgery Patients. Wang, L., Jiang, B., Shi, Y., et al.[2023]

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]

Rectus sheath block (RSB) significantly reduces postoperative rest pain scores in adults undergoing laparoscopic surgery, particularly in the first 2 hours after surgery, based on a systematic review of 9 trials involving 698 patients.

RSB not only improves pain control for up to 12 hours post-surgery but also decreases opioid consumption and related side effects, with no major adverse events reported, indicating its safety and efficacy as a pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety Profile of Rectus Sheath Block in Adult Laparoscopic Surgery: A Meta-analysis. Hamid, HKS., Ahmed, AY., Alhamo, MA., 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]

References

1. 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]

2. 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]

3. Japan pubmed.ncbi.nlm.nih.gov

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

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

Assessment of Total Ropivacaine Concentration in Blood after Bilateral Pecto-Intercostal Fascial Block Combined with Rectus Sheath Block in Cardiac Surgery Patients. [2023]

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

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

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

Efficacy and Safety Profile of Rectus Sheath Block in Adult Laparoscopic Surgery: A Meta-analysis. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

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