Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

NCT03482973 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2018P000044
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Sternal Pain

Keywords

Cardiopulmonary Bypass; Cardiac Surgery; Sternotomy

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

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

  48 hours

Secondary Outcomes (4)

• 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 Arms (2)

Interventional Bupivacaine

EXPERIMENTAL

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

Drug: Bupivacaine Group

Interventional Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Bupivacaine Group DRUG

20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).

Interventional Bupivacaine

Placebo OTHER

20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).

Interventional Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

This is a single-center study with restrictive inclusion may place some limitations on generalizability.

Results Point of Contact

• Title: Dr. Balachundhar Subramaniam
• Organization: Beth Israel Deaconess Medical Center

bsubrama@bidmc.harvard.edu

6176320706

Study Officials

• Balachundhar Subramaniam

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 29, 2018
• Study Start: June 21, 2018
• Primary Completion: November 25, 2019
• Study Completion: November 27, 2019
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Locations

US (1)