Pecto-Intercostal Fascial Plane Block Study

Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Opioid Use, Unspecified
• Intervention / Treatment: Drug: Bupivacaine Injection; Drug: Liposomal bupivacaine; Other: Saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PIFB intervention; bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)	Drug: Bupivacaine Injection; 10mL of 0.25% bupivacaine; Drug: Liposomal bupivacaine; 15mL of 133mg liposomal bupivacaine
Sham Comparator: Saline Control; bilateral PIFB with 25 mL saline only	Other: Saline; 25mL saline control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Intraoperative Opioid Consumption	Total intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups.	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	Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).	data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively
Maximum Pain Scores up to 72 Hours Postoperatively	Pain will be assessed, according to standard of care, every 4 hours using the 9-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). The number of Participants reporting a Maximum pain score at 72 hours postoperatively will be reported. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-9).	up to 72 hours post-op
Pain Score at 90 Days Postoperatively	Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain. Pain at 90 days postoperative will be surveyed by phone. Pain will be assessed participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).	up to 90 days post-op
Daily Opioid Consumption up to 72 Hours Postoperatively	Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups.	up to 72 hours post-op
Hours of Mechanical Ventilation After ICU Admission	Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.	up to 72 hours post-op
Number of Postoperative Days Until the First Bowel Movement	Return of bowel function will be measured in the number of postoperative days until the first bowel movement.	up to 72 hours post-op
Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)	Postoperative delirium episodes will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium. The number of of delirium episodes within 72 hours post-op will be determined.	up to 72 hours post-op
Number of Hours That the Patient is in the ICU	Duration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care.	up to 72 hours post-op
Number of Post-operative Days Until the Patient is Discharged	Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged.	Up to 7 days
Count of Participants Using Opioids at 90 Days Postoperatively	Patient use of opioids at 90 days will be obtained by phone call.	up to 90 days post-op

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Patrick Meyer, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): September 3, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: 2021-0111; A530900 (Other Identifier: UW Madison); SMPH/ANESTHESIOLOGY (Other Identifier: UW Madison); Protocol Version 01/11/2021 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes