At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Single-Blind, Active Control Trial to Compare Safety and Effectiveness Of Liposomal Bupivacaine (Exparel) to Standard Bupivacaine HCl (Marcaine) for Pain Management in Patients Undergoing Video-Assisted Thoracoscopic Lobectomy
In Brief
A Phase 3 clinical trial evaluating Liposomal Bupivacaine and Bupivacaine-Epinephrine for Non Small Cell Lung Cancer and Lung Cancer Stage 1. Completed, enrolled 57 participants across 1 site.
Detailed Summary
The purpose of this study is to assess pain management after elective thoracoscopic lobectomy. The study will compare two local anesthetics that are given intra-operatively during lobectomy to see which one helps in better pain control and to see which one helps decrease the need for opioid medications. Participants will receive either Marcaine (Bupivacaine-epinephrine 0.25%, 1:200,000) or Exparel (Bupivacaine liposomal (1.3%)) and the drug will be chosen in a random fashion. Participants will be followed during the hospital stay and for one year thereafter. An visual Scale will be administered to measure pain, and opioid drug use will be measured by calculating morphine equivalent dose on each day post surgery until discharge and thereafter on 30 day, 6 month and 12 month follow-up visits. Participants will be monitored for any drug related toxicity and other co-morbid conditions for a period on one year post surgery. Overall cost for the surgery and during in hospital stay post surgery will be collected and compared between the two treatment arms.
Study Details
Timeline
Interventions
Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site