Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

Study Overview
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Brief Summary
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This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Liposomal bupivacaine is a newer local anesthetic product and has not been compared to a combination of bupivacaine/epinephrine + dexamethasone in the context of pain control after robotic lung surgery.

Official Title
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Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial

Conditions
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Robotic Lung Surgery

Intervention / Treatment
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* Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine
* Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing robotic wedge resection or lobectomy for lung mass(es) Exclusion Criteria: emergency case history of opiate abuse chronic pain syndrome intravenous drug use chronic use of oral steroids pregnancy imprisonment body weight lower than 70 kg liver failure uninsured patients non-verbal patients or patients who are unable to rate their pain on a visual analogue pain scale history of allergic reaction to any of the drugs used in the study: bupivacaine, liposomal bupivacaine, dexamethasone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine/epinephrine + dexamethasone<br> | Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone<br>* Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 42 ml of 0.5% Bupivacaine/epinephrine with 8mg dexamethasone will be used.<br>|
| Active Comparator: Liposomal bupivacaine<br> | Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine<br>* Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 266mg of liposomal bupivacaine with 24 ml of 0.5% bupivacaine will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale pain scores | Visual Analogue Scale (VAS) pain score will be assessed for non-inferiority of bupivacaine/epinephrine +dexamethasone vs. liposomal bupivacaine. A non-inferiority margin of 2 points on the VAS scale will be considered non-inferior. | 24 hours post-surgery |