Status:
COMPLETED
Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Coronary Artery Disease
Postoperative Pain
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumpti...
Detailed Description
This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 62 subjects, with 25-30 in each group. Primary Outcomes: Pain scores on a 0-10 visual...
Eligibility Criteria
Inclusion
- Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes.
- Age 18-85 years of age
- BMI 18-50 kg/m2
- Weight \> 60 kg
Exclusion
- Left ventricular ejection fraction (LVEF) \< 30%
- Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)
- Inability to understand or speak English
- Allergy to bupivacaine or other amide local anesthetic
- Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)
- Chronic opioid consumption (daily oral morphine equivalent of \>20 mg) in the past three months
- Severe pulmonary or hepatic disease
- Neurological deficit or disorder
- Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years
- Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder
Key Trial Info
Start Date :
June 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04908449
Start Date
June 19 2023
End Date
November 14 2024
Last Update
November 17 2025
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226