Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients

NCT ID: NCT05676814

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-24
• Study Completion Date: 2023-06-24

Brief Summary

The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.

Detailed Description

This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.

Conditions

Analgesia; Sternotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pecto-intercostal Fascial Block (PIFB)

Subjects in this arm receive standard of care PIFB after surgery

Group Type: ACTIVE_COMPARATOR

Pecto-intercostal Fascial Block (PIFB)

Intervention Type: DRUG

PIFB done with bupivacaine and epinephrine

PIFB with adjuvants

Subjects in this arm receive standard of care PIFB with additional medications after surgery

Group Type: EXPERIMENTAL

PIFB with adjuvants

Intervention Type: DRUG

PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

Interventions

Pecto-intercostal Fascial Block (PIFB)

PIFB done with bupivacaine and epinephrine

Intervention Type: DRUG

PIFB with adjuvants

PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults between undergoing cardiac surgery involving sternotomy

Exclusion Criteria

• Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
• existing neurologic deficit in the chest wall;
• remaining intubated at the six hour point after block placement
• weight under 50kg
• undergoing emergency surgical procedures or urgent return to the operating room
• active endocarditis or mediastinitis
• moderate to severe right ventricular function before or after cardiopulmonary bypass
• reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella
• reliance on extracorporeal membrane oxygenation
• localized or systemic infection
• chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery)
• those who are pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Coleman, DO

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00090669

Identifier Type: -

Identifier Source: org_study_id