Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

Phase 4

Recruiting

• Conditions: Robotic Lung Surgery
• Interventions: Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone; Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine

• Registration Number: NCT03906617
• Lead Sponsor: The Cooper Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Study Start: 2019-04-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-12
• Primary Completion: 2022-04-10
• Study Completion: 2022-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine/epinephrine + dexamethasone	Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone	-
Liposomal bupivacaine	Intercostal nerve block and wound infiltration with liposomal bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale pain scores	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.

Trial Locations

Locations (1)

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States