Rectus Sheath Block in Cardiac Surgery

March 12, 2024 updated by: Ali Nima Shariat, Icahn School of Medicine at Mount Sinai

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 72 hours postoperatively
Amount of opioid consumption required postoperatively
72 hours postoperatively
VAS pain scores
Time Frame: 72 hours postoperatively
VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively
72 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in ICU
Time Frame: 72 hours
Amount of time spent in ICU postoperatively
72 hours
Length of hospital stay
Time Frame: 72 hours
Length of time spent in hospital postoperatively
72 hours
Time to extubation
Time Frame: 72 hours
Length of time requiring postoperative mechanical ventilation
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-23-00096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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