Pectoral Fascial Plane and Serratus Anterior Plane Blocks With Bupivacaine v. Liposomal Bupivacaine

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients will be randomized the day of surgery upon presentation to the operating room to either a treatment group (PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine) or a control group (PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline) using secure web-based randomization. Assignments will be based on computer-generated code. Clinicians will not be blinded to the intervention, but all outcomes will be assessed by research personnel who are blinded to the group assignment.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. Patients 18-85 years of age

2. Procedures using thoracic access ports or miniature thoracotomy incisions such as video assisted thoracic surgical (VATS) or robotic anatomic pulmonary resection (lobectomy, bilobectomy, and segmentectomy)

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 thoracic 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. Non-study nerve block that provides analgesia to the intercostal nerves

7. Active systemic or cardiopulmonary infection

8. Mechanical circulatory support devices

9. Allergy or contraindication to study local anesthetics

10. More than 15 mg/day morphine equivalents on at least 15 of the 30 preoperative days

11. Poorly controlled psychiatric disorders

12. Clinically important current neurologic deficit e.g. spinal cord injury, paralysis of extremity, any neurologic deficit in the region of the block

13. Active liver disease or cirrhosis

14. Pacemaker generator or breast implants ipsilateral to surgery

15. Previous participation in this study

16. eGFR <30 or chronic kidney disease