Pecto-Intercostal Fascial Plane Block Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2023-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgery Opioid Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, single-center, randomized, double-blind, controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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PIFB intervention

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

Group Type EXPERIMENTAL

Bupivacaine Injection

Intervention Type DRUG

10mL of 0.25% bupivacaine

Liposomal bupivacaine

Intervention Type DRUG

15mL of 133mg liposomal bupivacaine

Saline Control

bilateral PIFB with 25 mL saline only

Group Type SHAM_COMPARATOR

Saline

Intervention Type OTHER

25mL saline control

Interventions

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Bupivacaine Injection

10mL of 0.25% bupivacaine

Intervention Type DRUG

Liposomal bupivacaine

15mL of 133mg liposomal bupivacaine

Intervention Type DRUG

Saline

25mL saline control

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No