Pecto-Intercostal Fascial Plane Block Study

Phase 4

Completed

Conditions: Cardiac Surgery
Opioid Use, Unspecified

Interventions: Other: Saline
Drug: Bupivacaine Injection
Drug: Liposomal bupivacaine

Registration Number: NCT04928339

Lead Sponsor: University of Wisconsin, Madison

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Control	Saline	bilateral PIFB with 25 mL saline only
PIFB intervention	Liposomal bupivacaine	bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
PIFB intervention	Bupivacaine Injection	bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption 72 Hours Post-operatively	up to 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.

Secondary Outcome Measures

Name	Time	Method
Total Intraoperative Opioid Consumption	intraoperative period ranging from anesthesia start time to anesthesia end time	Total intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups.
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	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).
Maximum Pain Scores up to 72 Hours Postoperatively	up to 72 hours post-op	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).
Pain Score at 90 Days Postoperatively	up to 90 days post-op	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).
Daily Opioid Consumption up to 72 Hours Postoperatively	up to 72 hours post-op	Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups.
Hours of Mechanical Ventilation After ICU Admission	up to 72 hours post-op	Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.
Number of Postoperative Days Until the First Bowel Movement	up to 72 hours post-op	Return of bowel function will be measured in the number of postoperative days until the first bowel movement.
Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)	up to 72 hours post-op	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.
Number of Hours That the Patient is in the ICU	up to 72 hours post-op	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.
Number of Post-operative Days Until the Patient is Discharged	Up to 7 days	Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged.
Count of Participants Using Opioids at 90 Days Postoperatively	up to 90 days post-op	Patient use of opioids at 90 days will be obtained by phone call.