Rectus Sheath Block in Cardiac Surgery

NCT ID: NCT05833048

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-29

Study Completion Date

2026-09-07

Brief Summary

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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

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Conditions

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Cardiac Disease Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Rectus Sheath Block

Group Type EXPERIMENTAL

Rectus sheath block

Intervention Type PROCEDURE

Participants will receive an ultrasound guided rectus sheath block with local anesthetic

No block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rectus sheath block

Participants will receive an ultrasound guided rectus sheath block with local anesthetic

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Ali Nima Shariat

Associate Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mount Sinai Morningside Hospital Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ali Shariat, MD

Role: CONTACT

212-523-2500

Himani Bhatt, DO

Role: CONTACT

212-523-2500

Facility Contacts

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Ali Shariat, MD

Role: primary

212-523-2500

Other Identifiers

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STUDY-23-00096

Identifier Type: -

Identifier Source: org_study_id

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