Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03906617

Enrollment

Registered

2019-04-08

Start date

2019-04-10

Completion date

2022-06-10

Last updated

2021-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Robotic Lung Surgery

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.

Interventions

DRUGIntercostal 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.

DRUGIntercostal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactNoud van Helmond, MD

vanhelmond-noud@cooperhealth.edu856-968-7336

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026