Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-30

Study Completion Date

2021-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Thoracic Diseases Postoperative Pain Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Syringe with Obscuring Over-Wrap

Study Groups

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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.

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine Injection

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Johannes R. Kratz, MD

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

Responsibility Role PRINCIPAL_INVESTIGATOR