Pecto-Intercostal Fascial Plane Block Study

NCT04928339 | Completed Phase 4 Results FDA Drug

• 4 other identifiers: 2021-0111Protocol Version 01/11/2021A530900SMPH/ANESTHESIOLOGY
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.

Conditions

Cardiac Surgery; Opioid Use, Unspecified

Outcome Measures

Primary Outcomes (1)

• Total Opioid Consumption 72 Hours Post-operatively

  Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.

  up to 72 hours post-operatively

Secondary Outcomes (11)

• Total Intraoperative Opioid Consumption

  intraoperative period ranging from anesthesia start time to anesthesia end time

• Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op

  data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively

• Maximum Pain Scores up to 72 Hours Postoperatively

  up to 72 hours post-op

• Pain Score at 90 Days Postoperatively

  up to 90 days post-op

• Daily Opioid Consumption up to 72 Hours Postoperatively

  up to 72 hours post-op

Study Arms (2)

PIFB intervention

EXPERIMENTAL

bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)

Drug: Bupivacaine Injection; Drug: Liposomal bupivacaine

Saline Control

SHAM COMPARATOR

bilateral PIFB with 25 mL saline only

Other: Saline

Interventions

Bupivacaine Injection DRUG

10mL of 0.25% bupivacaine

PIFB intervention

Liposomal bupivacaine DRUG

15mL of 133mg liposomal bupivacaine

PIFB intervention

Saline OTHER

25mL saline control

Saline Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant provides consent to participate in study
• Ideal body weight (IBW) is \>50kg
• Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy
• Participant is undergoing an elective procedure

You may not qualify if:

• Participant is unable or unwilling to give consent
• Non-English speaking
• Known or believed to be pregnant or is currently breastfeeding
• Participant is a prisoner
• Clinically unstable per discretion of the Investigator
• Participant requires urgent/emergent surgery
• History of previous sternotomy
• Preoperative coagulopathy (INR \>1.4, platelets \<100,000) or ongoing anticoagulation or anti-platelet therapy (except aspirin 81mg)
• Allergy or sensitivity to amide-type local anesthetics, dexmedetomidine or ketamine
• Participant has decompensated heart failure
• Severe left ventricle dysfunction (defined quantitatively as an ejection fraction of less than or equal to 35%) or right ventricle dysfunction (defined qualitatively as "severe")
• Diagnosis of cirrhosis or end-stage liver disease
• Requires the use of mechanical circulatory support pre-operatively
• Participant uses chronic opioids (meaning at the time of the preoperative screening evaluation by the study team, the patient is prescribed and taking any opioid pain medication)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Simon ER, Mallery A, Silva J, de Biasi A, Osaki S, Krause BM, Meyer P. Superficial parasternal intercostal plane blocks with liposomal bupivacaine did not significantly reduce opioid use after cardiac surgery: a randomized clinical trial. Reg Anesth Pain Med. 2025 Aug 24:rapm-2025-106952. doi: 10.1136/rapm-2025-106952. Online ahead of print.

  PMID: 40850695 DERIVED

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Jeremy Sullivan
• Organization: University of Wisconsin - Madison

jasullivan@wisc.edu

6082639976

Study Officials

• Patrick Meyer, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Each study participant and OR anesthesia team, cardiac surgery team, cardiothoracic ICU team, and nursing staff caring for the participant will be blinded to the study drug the patient received. However, the anesthesia provider performing the block (separate from the provider caring for the patient in the operating room) will not be blinded to the study drug injected and will have access to all monitors deemed appropriate by the primary team caring for the participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, single-center, randomized, double-blind, controlled trial

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: March 28, 2022
• Primary Completion: September 3, 2023
• Study Completion: November 30, 2023
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)