Rectus Sheath Block in Cardiac Surgery
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedStudy Start
First participant enrolled
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2026
ExpectedSeptember 23, 2025
September 1, 2025
1.7 years
April 17, 2023
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Opioid consumption
Amount of opioid consumption required postoperatively
72 hours postoperatively
VAS pain scores
VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively
72 hours postoperatively
Secondary Outcomes (3)
Length of stay in ICU
72 hours
Length of hospital stay
72 hours
Time to extubation
72 hours
Study Arms (2)
Rectus Sheath Block
EXPERIMENTALNo block
NO INTERVENTIONInterventions
Participants will receive an ultrasound guided rectus sheath block with local anesthetic
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Morningside Hospital Center
New York, New York, 10023, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthesiology
Study Record Dates
First Submitted
April 17, 2023
First Posted
April 27, 2023
Study Start
July 29, 2024
Primary Completion
March 30, 2026
Study Completion (Estimated)
September 7, 2026
Last Updated
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share