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Local Anesthetic

Exparel vs Bupivacaine for Postoperative Pain After Thoracoscopy

Phase 4

Recruiting

Led By Zoulfira Nisnevitch-Savarese, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including VATS wedge resection/segmentectomy, VATS lobectomy, robot assisted thoracoscopic wedge resection/segmentectomy, and robot assisted thoracoscopic lobectomy procedures

Be older than 18 years old

Must not have

Patients with liver dysfunction

Patients with previous ipsilateral thoracic surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0.5, 1, 2, 4, 8, 12, 24, 32, 48, 72 hours after intraoperative multiple level intercostal injections.

Awards & highlights

Summary

This trial will assess the pharmacokinetics of liposomal bupivacaine after multilevel intercostal injections of the local anesthetic for pain control during and after thoracoscopic surgeries.

Who is the study for?

Adults over 18 undergoing specific minimally invasive chest surgeries can join this trial. Excluded are those under 18, pregnant or breastfeeding women, patients on preoperative narcotics for chronic pain near the surgery site, non-English speakers, individuals weighing less than 48 kg, and those with dementia, kidney dysfunction, liver issues, allergies to local anesthetics or previous similar surgeries.

What is being tested?

The study is testing if liposomal bupivacaine (Exparel) given during chest surgery controls pain as effectively as plain bupivacaine without reaching toxic levels in the blood. It also looks at whether Exparel reduces opioid use and post-surgery pain up to three months later.

What are the potential side effects?

Possible side effects include reactions at the injection site like numbness or tingling sensations due to nerve blockage from bupivacaine. There's a risk of toxicity if levels get too high causing symptoms such as confusion or heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and will have a minimally invasive chest surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have liver problems.

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I have had surgery on the same side of my chest before.

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I weigh less than 48 kg.

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I have had surgery on my spine in the chest area.

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I have a chronic pain condition like CRIPS, fibromyalgia, or neuropathy.

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I am taking pain medication for chronic pain near where I will have surgery.

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I do not speak English.

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I am under 18 years old.

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I am undergoing a procedure to remove part of the pleura or to fuse the pleura.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0.5, 1, 2, 4, 8, 12, 24, 32, 48, 72 hours after intraoperative multiple level intercostal injections.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0.5, 1, 2, 4, 8, 12, 24, 32, 48, 72 hours after intraoperative multiple level intercostal injections.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5, 1, 2, 4, 8, 12, 24, 32, 48, 72 hours after intraoperative multiple level intercostal injections. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Plasma concentration of bupivacaine

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExparelExperimental Treatment1 Intervention

Intercostal injection of 266mg of Exparel diluted to 30 ml.

Group II: BupivacaineActive Control1 Intervention

Intercostal injection of 0.5% Bupivacaine 2 mg/kg dose diluted to 30 ml.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exparel

2014

Completed Phase 4

~1620

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

504 Previous Clinical Trials

2,795,900 Total Patients Enrolled

Zoulfira Nisnevitch-Savarese, MDPrincipal Investigator - Penn State Hershey College of Medicine

Penn State Geisinger Rehabilitation Center, Penn State Milton S. Hershey Medical Center, The Milton S Hershey Medical Center Physcians Group

Orenburg Medical Inst (Medical School)

Umdnj-New Jersey Medical Sch (Residency)

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03737292 — Phase 4

Pharmacokinetics Research Study Groups: Exparel, Bupivacaine

Pharmacokinetics Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT03737292 — Phase 4

Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03737292 — Phase 4

~6 spots leftby Oct 2025

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