Pectoralis and Serratus Muscle Blocks

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Post Operative Pain Control

Treatments: Drug: Exparel 266 MG Per 20 ML Injection; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03743194

18-1125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

210 participants in 2 patient groups, including a placebo group

Bupi HCl plus liposomal bupi

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Exparel 266 MG Per 20 ML Injection

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo