Clinical trial NCT03743194: Pectoralis and Serratus Muscle Blocks
Official title: Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain Control
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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;
11. Poorly controlled psychiatric disorders;
12. Clinically important current neurologic deficit;
13. Active liver disease or cirrhosis;
14. Pacemaker generator or breast implants ipsilateral to surgery;
15. Previous participation in this study.

Primary outcomes:
measure: Overall Benefit Analgesia Score
timeFrame: Postoperative day 1-3
Secondary outcomes:
measure: Cumulative Opioid Consumption Over Postoperative 3 Days
timeFrame: 72 hours postoperative
measure: Postoperative FEV1
timeFrame: Postoperatively day 1 -3
measure: Postoperative FVC
timeFrame: Postoperative day 1 -3
measure: Postoperative Peak Flow
timeFrame: Postoperative day 1-3
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Andrej Alfirevic, MD
role: PRINCIPAL_INVESTIGATOR
References: