Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03906617
• Other study ID #: 18039
• Status: Recruiting
• Phase: Phase 4
• Start date: April 10, 2019
• Est. completion date: June 10, 2022

Study information

• Verified date: November 2021
• Source: The Cooper Health System
• Contact: Noud van Helmond, MD
• Phone: 856-968-7336
• Email: vanhelmond-noud[@]cooperhealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Robotic Lung Surgery

Intervention

Drug:
• Intercostal nerve block and wound infiltration with liposomal bupivacaine
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.
• Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone
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.

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

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