Rectus Sheath Block in Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Cardiac Disease; Postoperative Pain
• Interventions: Procedure: Rectus sheath block

• Registration Number: NCT05833048
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-27
• Study Start: 2024-07-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Adults 18-85 years old
  2. Scheduled to undergo cardiac procedures involving chest tubes
  3. Male or female

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Exclusion Criteria

• An individual who meets any of the following criteria will be excluded from participation in this study:

  1. ASA class V
  2. Urgent or emergent surgery
  3. Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
  4. History of substance abuse or chronic opioid use
  5. Patient refusal or inability to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectus Sheath Block	Rectus sheath block	-

Primary Outcome Measures

Name	Time	Method
VAS pain scores	72 hours postoperatively	VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively
Opioid consumption	72 hours postoperatively	Amount of opioid consumption required postoperatively

Secondary Outcome Measures

Name	Time	Method
Length of stay in ICU	72 hours	Amount of time spent in ICU postoperatively
Length of hospital stay	72 hours	Length of time spent in hospital postoperatively
Time to extubation	72 hours	Length of time requiring postoperative mechanical ventilation

Trial Locations

Locations (1)

Mount Sinai Morningside Hospital Center; 🇺🇸 New York, New York, United States