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Clinical Trials/NCT03482973
NCT03482973
Completed
Phase 3

Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Beth Israel Deaconess Medical Center1 site in 1 country80 target enrollmentJune 21, 2018

Overview

Phase
Phase 3
Intervention
Bupivacaine Group
Conditions
Coronary Artery Disease
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
80
Locations
1
Primary Endpoint
Opioid Consumption
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.

Detailed Description

The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline. Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through: (Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.

Registry
clinicaltrials.gov
Start Date
June 21, 2018
End Date
November 27, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Balachundhar Subramaniam

Associate Professor of Anesthesia

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Interventional Bupivacaine

20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1

Intervention: Bupivacaine Group

Interventional Placebo

20 cc of saline on each side of the sternum at two time points after surgery and POD1

Intervention: Placebo

Outcomes

Primary Outcomes

Opioid Consumption

Time Frame: 48 hours

Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).

Secondary Outcomes

  • Pain Scores(At 6-8 hourly intervals every day until discharge or 4 days)
  • ICU Length of Stay(Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days)
  • Hospital Length of Stay(Measured in days admitted in the hospital, an average of 5 days)
  • Number of Participants With Complications(7 days post-op on an average)

Study Sites (1)

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