Rectus Sheath Block in Cardiac Surgery

Postoperative Pain Clinical Trial

Official title:

Rectus Sheath Block in Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05833048
• Other study ID #: STUDY-23-00096
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Ali Shariat, MD
• Phone: 212-523-2500
• Email: AliNima.Shariat[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Postoperative Pain

Intervention

Procedure:
• Rectus sheath block
Participants will receive an ultrasound guided rectus sheath block with local anesthetic

Locations

Country	Name	City	State
United States	Mount Sinai Morningside Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Amount of opioid consumption required postoperatively	72 hours postoperatively
Primary	VAS pain scores	VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively	72 hours postoperatively
Secondary	Length of stay in ICU	Amount of time spent in ICU postoperatively	72 hours
Secondary	Length of hospital stay	Length of time spent in hospital postoperatively	72 hours
Secondary	Time to extubation	Length of time requiring postoperative mechanical ventilation	72 hours