Pectoralis and Serratus Muscle Blocks

Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures

NCT03743194•The Cleveland Clinic

Summary

The overall research plan is PECS/SAP blocks with liposomal bupivacaine improve the Overall Benefit Analgesia Score averaged over the postoperative days 1, 2, and 3. A 20% reduction on geometric means (i.e., true ratio of geometric means of 0.80) in OBAS will be considered the minimal clinically important benefit.

Detailed Description

The primary aim is to determine whether a PECS/SAP block, using a mixture of bupivacaine and liposomal bupivacaine, provides superior recovery compared to routine parenteral and enteral analgesia in patients recovering from MICS. The primary outcome will be the simple multi-dimensional quality assessment, Overall Benefit Analgesia Score (OBAS score).53 Our secondary aims are to: 1) compare cumulative postoperative opioid consumption (pain medications administered over one-day periods quantified as morphine equivalents and provided by the EMR for the day of surgery and postoperative days 1, 2, and 3; 2) evaluate respiratory mechanics (forced expiratory volume in first minute (FEV1), forced vital capacity (FVC) and peak flow) after extubation on the postoperative days 1, 2 and 3 while patients remain hospitalized; and, (3) evaluate the Quality-of-Recovery-15 score on the postoperative days 1, 2 and 3.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-85 years old;
•2. Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy

Exclusion Criteria

•1. Weight less than 50 kg;
•2. Pregnancy or lactation;
•3. Emergency surgery and patients transferred from the ICU to the operating room;
•4. Redo cardiothoracic surgery or post-operative reoperation within 72 hours of index procedure (including minor chest wall procedures including tube thoracostomy, thoracentesis or percutaneous drain placement);
•5. Anticipated endotracheal intubation \> 24 hours;
•6. Anticipated non-study nerve block that provides analgesia to the intercostal nerves;
•7. Active systemic or cardiopulmonary infection;
•8. Mechanical circulatory support;
•9. Allergy or contraindication to study local anesthetics;
•10. Current chronic pain or routine opioid use (patients on chronic enteral opioids like Percocet or Vicodin) in a dose of \> 30 mg of morphine-milligram-equivalents for at least 10 days in last 30 days;
+5 more criteria

Locations (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Key Dates

Start Date

December 14, 2021

Primary Completion Date

February 28, 2022

Completion Date

March 14, 2022

Last Updated

October 23, 2025

Enrollment

210

ACTUAL participants

Conditions

Post Operative Pain Control

Interventions

Exparel 266 MG Per 20 ML Injection

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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