Clinical trial NCT04928339: Pecto-Intercostal Fascial Plane Block Study
Official title: Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Opioid Use, Unspecified
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-center, randomized, double-blind, controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total Opioid Consumption 72 Hours Post-operatively
timeFrame: up to 72 hours post-operatively
Secondary outcomes:
measure: Total Intraoperative Opioid Consumption
timeFrame: intraoperative period ranging from anesthesia start time to anesthesia end time
measure: Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
timeFrame: data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively
measure: Maximum Pain Scores up to 72 Hours Postoperatively
timeFrame: up to 72 hours post-op
measure: Pain Score at 90 Days Postoperatively
timeFrame: up to 90 days post-op
measure: Daily Opioid Consumption up to 72 Hours Postoperatively
timeFrame: up to 72 hours post-op
measure: Hours of Mechanical Ventilation After ICU Admission
timeFrame: up to 72 hours post-op
measure: Number of Postoperative Days Until the First Bowel Movement
timeFrame: up to 72 hours post-op
measure: Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)
timeFrame: up to 72 hours post-op
measure: Number of Hours That the Patient is in the ICU
timeFrame: up to 72 hours post-op
measure: Number of Post-operative Days Until the Patient is Discharged
timeFrame: Up to 7 days
measure: Count of Participants Using Opioids at 90 Days Postoperatively
timeFrame: up to 90 days post-op
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Patrick Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: