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.
- Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery?
- 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
Ali Nima Shariat
Associate Professor of Anesthesiology
Icahn School of Medicine at Mount Sinai
Study Sites (1)
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