Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Sternal Pain
• Intervention / Treatment: Drug: Bupivacaine Group; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Patients 18 years of age or older
• Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.

Exclusion Criteria

• Current participation in another interventional study
• Preoperative LVEF < 30%
• Use of mechanical circulatory support
• Emergent procedures
• Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts
• Minimally invasive cardiac procedures or those with thoracotomy approach
• Patients receiving other modalities of regional anesthesia like intrathecal morphine
• Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
• Current use of TCA, gabapentin, or pregabalin
• Hypersensitivity to bupivacaine
• Women who are pregnant or breastfeeding
• Non English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Bupivacaine; 20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1	Drug: Bupivacaine Group; 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
Placebo Comparator: Interventional Placebo; 20 cc of saline on each side of the sternum at two time points after surgery and POD1	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score.	At 6-8 hourly intervals every day until discharge or 4 days
ICU Length of Stay	Total duration of stay in ICU for the index admission	Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
Hospital Length of Stay	Their stay in the hospital for the index admission	Measured in days admitted in the hospital, an average of 5 days
Number of Participants With Complications	This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block	7 days post-op on an average

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Cardiopulmonary Bypass; Sternotomy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2018P000044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No