Rectus Sheath Block in Cardiac Surgery

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05833048
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27.5
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease; Postoperative Pain	Procedure: Rectus sheath block	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Rectus Sheath Block in Cardiac Surgery
• Anticipated Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: Aug 30, 2025
• Anticipated Study Completion Date: Aug 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rectus Sheath Block	Procedure: Rectus sheath block; Participants will receive an ultrasound guided rectus sheath block with local anesthetic
No Intervention: No block

Outcome Measures

Primary Outcome Measures

1. Opioid consumption [72 hours postoperatively]

   Amount of opioid consumption required postoperatively

2. VAS pain scores [72 hours postoperatively]

   VAS pain scores recorded postoperatively

Secondary Outcome Measures

1. Length of stay in ICU [72 hours]

   Amount of time spent in ICU postoperatively

2. Length of hospital stay [72 hours]

   Length of time spent in hospital postoperatively

3. Time to extubation [72 hours]

   Length of time requiring postoperative mechanical ventilation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Morningside Hospital Center	New York	New York	United States	10023

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ali Nima Shariat, Associate Professor of Anesthesiology, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT05833048
• Other Study ID Numbers: STUDY-23-00096
• First Posted: Apr 27, 2023
• Last Update Posted: Apr 27, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ali Nima Shariat, Associate Professor of Anesthesiology, Icahn School of Medicine at Mount Sinai: cardiac surgery; regional anesthesia
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Apr 27, 2023