Pectoralis and Serratus Muscle Blocks

  • STATUS
    Recruiting
  • End date
    Dec 28, 2022
  • participants needed
    192
  • sponsor
    The Cleveland Clinic
Updated on 28 January 2021

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 2-point reduction in OBAS will be considered the minimal clinically important benefit.

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.

Details
Condition Post Operative Pain Control
Treatment Placebo, Exparel 266 MG Per 20 ML Injection
Clinical Study IdentifierNCT03743194
SponsorThe Cleveland Clinic
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

18-85 years old
Elective MICS for isolated aortic or mitral valve via anterior or anterolateral thoracotomy approach with or without robotic assistance

Exclusion Criteria

Weight less than 50 kg
Pregnancy or lactation
Emergency surgery and patients transferred from the ICU to the operating room
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)
Anticipated endotracheal intubation > 24 hours
Anticipated non-study nerve block that provides analgesia to the intercostal nerves
Active systemic or cardiopulmonary infection
Mechanical circulatory support
Allergy or contraindication to study local anesthetics
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
Poorly controlled psychiatric disorders
Clinically important current neurologic deficit
Active liver disease or cirrhosis
Pacemaker generator or breast implants ipsilateral to surgery
Previous participation in this study
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