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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 18 and will have a minimally invasive chest surgery.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
497 Previous Clinical Trials
2,799,968 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver problems.My surgeon thinks it's likely my lung surgery might change from a keyhole to an open procedure.I have had surgery on the same side of my chest before.You are allergic to the local anesthetics and pain medications used in the study.I weigh less than 48 kg.Your creatinine level in your blood is higher than 1.5mg/dl.I have had surgery on my spine in the chest area.I have a chronic pain condition like CRIPS, fibromyalgia, or neuropathy.I am over 18 and will have a minimally invasive chest surgery.I am taking pain medication for chronic pain near where I will have surgery.I do not speak English.I am under 18 years old.I am undergoing a procedure to remove part of the pleura or to fuse the pleura.You have difficulty in telling others about your pain, like if you have memory problems or changes in thinking ability.
Research Study Groups:
This trial has the following groups:- Group 1: Exparel
- Group 2: Bupivacaine
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the typical applications of Exparel?
"Exparel has the capacity to address permphigus, acute nonspecific tenosynovitis, and general anesthesia."
Answered by AI
What other experiments have been conducted to assess the efficacy of Exparel?
"According to the data available, there are presently 109 research initiatives investigating Exparel. Of those active studies, 18 of them are in their final stage. Most trials for this treatment are conducted in Philadelphia, but 144 medical centres across the USA have been enlisted to participate."
Answered by AI
How many subjects are participating in this investigation?
"Affirmative. The clinicaltrials.gov website reveals that this medical trial is actively recruiting subjects, having first been posted on April 9th 2019 and most recently updated on May 19th 2022. 40 volunteers are required to take part in the research across one site."
Answered by AI
Is enrollment open for this trial?
"Yes, there is confirmation on clinicaltrials.gov that this study is still as of May 19th 2022 actively searching for test subjects. The trial was first listed April 9th 2019 and has 40 openings at one site."
Answered by AI
Is the utilization of Exparel likely to bring about any adverse reactions?
"Because Exparel has been validated in Phase 4 trials, it is considered a safe treatment and thus received a score of 3."
Answered by AI
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