Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

Phase 3

Completed

• Conditions: Opioid Use; Thoracic Diseases; Postoperative Pain
• Interventions: Drug: Bupivacaine Injection; Drug: Liposomal bupivacaine

• Registration Number: NCT03508830
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-26
• Study Start: 2018-12-30
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Results First Submitted: 2021-04-13
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Results First Posted: 2021-06-08
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Robotic or Video-Assisted Lung Resection for All Indications

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Bupivacaine	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. 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.
Liposomal Bupivacaine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States