Pecto-Intercostal Fascial Plane Block Study

University of Wisconsin (UW)

Status and phase

Completed

Phase 4

Conditions

Cardiac Surgery

Opioid Use, Unspecified

Treatments

Drug: Bupivacaine Injection

Drug: Liposomal bupivacaine

Other: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT04928339

Protocol Version 01/11/2021 (Other Identifier)

2021-0111

SMPH/ANESTHESIOLOGY (Other Identifier)

A530900 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Thousands of heart surgeries are performed every day in the United States. Unattenuated perioperative pain has been shown to contribute to increased morbidity, mortality, length of stay, and healthcare costs. Practice guidelines from the American Society of Regional Anesthesiologists recommend pre-incision techniques to reduce perioperative pain, however in cardiac surgery, there are no commonly used techniques to follow this recommendation. The PIFB is a newly described fascial plane block and existing literature supports the safety and efficacy of the PIFB in cardiac surgery patients. However, there are no randomized controlled trials evaluating this technique with a long-acting depot local anesthetic.

The purpose of this study is to determine whether bilateral pecto-intercostal fascial plane blocks with liposomal bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). The primary hypothesis is that patients receiving effective regional anesthesia with liposomal bupivacaine via PIFB will demonstrate a clinically significant (25%) reduction in total daily opioid consumption through 72 hours postoperatively compared to patients receiving standard of care without effective regional anesthesia (saline only via PIFB).

This study is a prospective, single-center, randomized, double-blind, controlled trial to evaluate whether bilateral pecto-intercostal fascial plane blocks with liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline).

The participants will be randomized to receive bilateral PIFB with a mixture of standard and liposomal bupivacaine or bilateral PIFB with saline only. Recovery characteristics, including opioid consumption, pain scores, duration of mechanical ventilation, ICU length of stay, hospital length of stay, side effects, and chronic opioid use will be evaluated.

Enrollment

100 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)