Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

NCT03508830 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: P0530291
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liposomal Bupivacaine; Intercostal Nerve Block; Minimally Invasive Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Average Daily In-Hospital Pain Score

  Average over Length of Hospitalization - Up to 1 Week

• Number of Participants With Postoperative Pneumonia

  Index Hospitalization following Surgery until Discharge - Up to 1 Week

• Length of Stay

  Index Hospitalization following Surgery until Discharge - Up to 1 Week

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

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

Standard Bupivacaine

ACTIVE COMPARATOR

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

Interventions

Liposomal bupivacaine DRUG

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.

Liposomal Bupivacaine

Bupivacaine Injection DRUG

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.

Standard Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Robotic or Video-Assisted Lung Resection for All Indications

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Thoracic Diseases; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Greg J. Haro
• Organization: University of California, San Francisco

greg.haro@ucsf.edu

415-353-7502

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Syringe with Obscuring Over-Wrap
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery Division of Adult Cardiothoracic Surgery; Van Auken Endowed Chair in Thoracic Oncology; Director, Minimally Invasive and Robotic Thoracic Surgery; Associate Director, Thoracic Surgery Residency Program

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 26, 2018
• Study Start: December 30, 2018
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)