NCT03482973

Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Sternal Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine Group	20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
OTHER	Placebo	20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).

Timeline

• Start date: 2018-06-21
• Primary completion: 2019-11-25
• Completion: 2019-11-27
• First posted: 2018-03-29
• Last updated: 2020-08-03
• Results posted: 2020-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study