Phase 4 N=210 Randomized Double-blind Treatment

Pectoralis and Serratus Muscle Blocks

Post Operative Pain Control

Bottom Line

View on ClinicalTrials.gov: NCT03743194 ↗

Enrolled (actual)

210

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Overall Benefit Analgesia Score — 4; 5; 3; 3 score on a scale — p=0.75

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Exparel 266 MG Per 20 ML Injection (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Benefit Analgesia Score	4; 5; 3; 3; 2; 2	0.75
SECONDARY Cumulative Opioid Consumption Over Postoperative 3 Days	118; 113	0.94
SECONDARY Postoperative FEV1	1.3; 1.3; 1.4; 1.4; 1.6; 1.6	0.36
SECONDARY Postoperative FVC	1.7; 1.7; 1.8; 1.9; 2.1; 2.2	0.51
SECONDARY Postoperative Peak Flow	3.1; 3.0; 3.2; 3.2; 3.4; 3.6	0.36

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.

Eligibility Criteria

Inclusion Criteria

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03743194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.