Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

NCT ID: NCT03906617

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2022-06-10

Brief Summary

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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

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Conditions

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Robotic Lung Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bupivacaine/epinephrine + dexamethasone

Group Type EXPERIMENTAL

Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone

Intervention Type DRUG

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.

Liposomal bupivacaine

Group Type ACTIVE_COMPARATOR

Intercostal nerve block and wound infiltration with liposomal bupivacaine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cooper Health System

OTHER

Sponsor Role lead

Responsible Party

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Kingsuk Ganguly, M.D.

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cooper University Hospital

Camden, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Noud van Helmond, MD

Role: CONTACT

Phone: 856-968-7336

Email: [email protected]

Facility Contacts

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Noud van Helmond, MD

Role: primary

Other Identifiers

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18039

Identifier Type: -

Identifier Source: org_study_id