Pectoralis and Serratus Muscle Blocks

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Bupi HCl plus liposomal bupi	Exparel 266 MG Per 20 ML Injection	Pectoral fascial plane or serratus anterior plane blocks (PECSII/SAP blocks) with bupivacaine HCl plus liposomal bupivacaine. An ultrasound guided pectoral fascial plane blocks (PECS I and II blocks) and Serratus anterior plane (SAP) block with injection of the local anesthetic.
Control Group	Placebo	Standard parenteral analgesia technique with or without incisional local anesthetic infiltration: patients randomized to control group will be given parenteral opioids (such as fentanyl or hydromorphone) until they are converted to the enteral medications such as Percocet.
Bupi HCl plus liposomal bupi	Placebo	Pectoral fascial plane or serratus anterior plane blocks (PECSII/SAP blocks) with bupivacaine HCl plus liposomal bupivacaine. An ultrasound guided pectoral fascial plane blocks (PECS I and II blocks) and Serratus anterior plane (SAP) block with injection of the local anesthetic.

Primary Outcome Measures

Name	Time	Method
Overall Benefit Analgesia Score	Postoperative day 1-3	Our primary outcome, Overall Benefit Analgesia Score (OBAS), was measured daily by investigators blinded to treatment on postoperative Days 1 to 3.Potential scores of the seven-item questionnaire ranged from 0 to 28 points. Higher scores means worse conditions.

Secondary Outcome Measures

Name	Time	Method
Postoperative FEV1	Postoperatively day 1 -3	Pulmonary Mechanics measure: The FEV1 (forced expiratory volume in 1 seconds) in litters, measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.
Cumulative Opioid Consumption Over Postoperative 3 Days	72 hours postoperative	Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents)
Postoperative FVC	Postoperative day 1 -3	Pulmonary Mechanics measure: the FVC (Forced Vital Capacity) in litters will be measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.
Postoperative Peak Flow	Postoperative day 1-3	Pulmonary Mechanics measure: the peak flow (peak expiratory flow) in litters per second will be measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.