Back to resultsRectus Sheath Block in Cardiac Surgery
Primary Purpose
Cardiac Disease, Postoperative Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rectus sheath block
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Disease focused on measuring cardiac surgery, regional anesthesia
Eligibility Criteria
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
Sites / Locations
- Mount Sinai Morningside Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rectus Sheath Block
No block
Arm Description
Outcomes
Primary Outcome Measures
Opioid consumption
Amount of opioid consumption required postoperatively
VAS pain scores
VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively
Secondary Outcome Measures
Length of stay in ICU
Amount of time spent in ICU postoperatively
Length of hospital stay
Length of time spent in hospital postoperatively
Time to extubation
Length of time requiring postoperative mechanical ventilation
Full Information
NCT ID
NCT05833048
First Posted
April 17, 2023
Last Updated
May 4, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05833048
Brief Title
Rectus Sheath Block in Cardiac Surgery
Official Title
Rectus Sheath Block in Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Postoperative Pain
Keywords
cardiac surgery, regional anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rectus Sheath Block
Arm Type
Experimental
Arm Title
No block
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Rectus sheath block
Intervention Description
Participants will receive an ultrasound guided rectus sheath block with local anesthetic
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Amount of opioid consumption required postoperatively
Time Frame
72 hours postoperatively
Title
VAS pain scores
Description
VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively
Time Frame
72 hours postoperatively
Secondary Outcome Measure Information:
Title
Length of stay in ICU
Description
Amount of time spent in ICU postoperatively
Time Frame
72 hours
Title
Length of hospital stay
Description
Length of time spent in hospital postoperatively
Time Frame
72 hours
Title
Time to extubation
Description
Length of time requiring postoperative mechanical ventilation
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Shariat, MD
Phone
212-523-2500
Email
AliNima.Shariat@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Himani Bhatt, DO
Phone
212-523-2500
Email
himani.bhatt@mountsinai.org
Facility Information:
Facility Name
Mount Sinai Morningside Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Shariat, MD
Phone
212-523-2500
Email
AliNima.Shariat@mountsinai.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rectus Sheath Block in Cardiac Surgery
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