Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

Study Overview
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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.

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

Conditions
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Thoracic Diseases, Postoperative Pain, Opioid Use

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine<br>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<br>* 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.<br>|
| Active Comparator: Standard Bupivacaine<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposomal Bupivacaine, Intercostal Nerve Block, Minimally Invasive Thoracic Surgery