Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

Phase 4RecruitingNCT03906617

The Cooper Health System34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Robotic Lung Surgery

Interventions

Intercostal nerve block and wound infiltration with liposomal bupivacaineDRUG

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 + dexamethasoneDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Cooper University Hospital

Camden, New Jersey, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 24 hours post-surgery

Central Contacts

Noud van Helmond, MD

CONTACT

856-968-7336 vanhelmond-noud@cooperhealth.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.