Cooper University Hospital
Camden, New Jersey, 08103, United States
Location status: Recruiting
Recruiting
NCT Number: NCT03906617
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Intercostal nerve block and wound infiltration with liposomal bupivacaine
DrugIntercostal 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.
Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone
DrugIntercostal 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.
Primary outcomes
-
Visual Analogue Scale pain scores
Time frame: 24 hours post-surgery
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
The Cooper Health System
Other
Registry information
Official study 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
Important dates
- Study start
- 2019
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Apr 8, 2019
- Registry last updated
- Nov 12, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.