Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status and phase

Completed
Phase 3

Conditions

Postoperative Pain
Opioid Use
Thoracic Diseases

Treatments

Drug: Bupivacaine Injection
Drug: Liposomal bupivacaine

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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