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Clinical Trials/NCT05833048
NCT05833048RecruitingNot Applicable

Rectus Sheath Block in Cardiac Surgery

Icahn School of Medicine at Mount Sinai1 site in 1 country75 target enrollmentStarted: July 29, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
75
Locations
1
Primary Endpoint
VAS pain scores

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
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:
  • Adults 18-85 years old
  • Scheduled to undergo cardiac procedures involving chest tubes
  • Male or female

Exclusion Criteria

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • ASA class V
  • Urgent or emergent surgery
  • Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
  • History of substance abuse or chronic opioid use
  • Patient refusal or inability to consent

Arms & Interventions

Rectus Sheath Block

Experimental

Intervention: Rectus sheath block (Procedure)

No block

No Intervention

Outcomes

Primary Outcomes

VAS pain scores

Time Frame: 72 hours postoperatively

VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively

Opioid consumption

Time Frame: 72 hours postoperatively

Amount of opioid consumption required postoperatively

Secondary Outcomes

  • Length of stay in ICU(72 hours)
  • Length of hospital stay(72 hours)
  • Time to extubation(72 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Nima Shariat

Associate Professor of Anesthesiology

Icahn School of Medicine at Mount Sinai

Study Sites (1)

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