Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Thoracic Diseases; Opioid Use
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivacaine Injection

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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.	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.
Active Comparator: Standard 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 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily In-Hospital Use of Opioids	Measured in Oral Morphine Equivalents per Day	Average over Entire Length of Hospitalization (Up to 1 Week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily In-Hospital Pain Score	Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).	Average over Length of Hospitalization - Up to 1 Week
Number of Participants With Postoperative Pneumonia	Pneumonia (Y/N)	Index Hospitalization following Surgery until Discharge - Up to 1 Week
Length of Stay	Measured in Days	Index Hospitalization following Surgery until Discharge - Up to 1 Week

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2018
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Liposomal Bupivacaine; Intercostal Nerve Block; Minimally Invasive Thoracic Surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: P0530291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No