NCT03508830

Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.

Conditions

• Thoracic Diseases
• Postoperative Pain
• Opioid Use

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
DRUG	Bupivacaine Injection	5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.

Timeline

• Start date: 2018-12-30
• Primary completion: 2021-01-30
• Completion: 2021-01-30
• First posted: 2018-04-26
• Last updated: 2021-06-08
• Results posted: 2021-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study