Robotic Lung Surgery Clinical Trial
Official title:
Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
NCT number | NCT03906617 |
Other study ID # | 18039 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 10, 2019 |
Est. completion date | June 10, 2022 |
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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | June 10, 2022 |
Est. primary completion date | April 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cooper University Hospital | Camden | New Jersey |
Lead Sponsor | Collaborator |
---|---|
The Cooper Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |