Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain; Opioid Use; Thoracic Diseases

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03508830

P0530291

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Robotic or Video-Assisted Lung Resection for All Indications

Exclusion criteria

• Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
• Extra-Thoracic Procedures
• Hypersensitivity to Amide Local Analgesia
• Cardiac Conduction Abnormalities
• Hepatic Dysfunction
• Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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91 participants in 2 patient groups

Liposomal Bupivacaine

Experimental group

Description:

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 Preparation: 266mg (20cc) Liposomal Bupivacaine admixed with 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) and varied 0.9% normal saline volume for total volume of 60cc.

Treatment:

Drug: Liposomal bupivacaine

Standard Bupivacaine

Active Comparator group

Description:

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 Preparation - 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) admixed with varied 0.9% normal saline volume for total volume of 60cc.

Treatment:

Drug: Bupivacaine Injection