Phase 4
Completed N=210
Pectoralis and Serratus Muscle Blocks
Post Operative Pain Control
Source: ClinicalTrials.gov NCT03743194 ↗
Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Overall Benefit Analgesia Score — 4; 5; 3; 3 score on a scale — p=0.75
◆ Published Evidence
Established
33citations · ~11 / year
Serratus anterior and pectoralis plane blocks for robotically assisted mitral valve repair: a randomised clinical trial.
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.
Linked Publications
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Serratus anterior and pectoralis plane blocks for robotically assisted mitral valve repair: a randomised clinical trial.
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 |
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.
Data sourced from ClinicalTrials.gov (NCT03743194) and the linked publication. 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. Informational only — not medical advice.