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NCT03737292 · ClinicalTrials.gov registry record · Phase 4
Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
A Phase 4 study of Pain, Postoperative and Pharmacokinetics, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03737292 is a Phase 4 study of Pain, Postoperative and Pharmacokinetics that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 40 participants, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03737292, a Phase 4 study of Pain, Postoperative and Pharmacokinetics, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries. The specific aim of this study is to evaluate plasma concentration of bupivacaine after intraoperative intercostal injections of 266 mg of liposomal bupivacaine and compare it to plasma concentrations of bupivacaine after intercostal injections of 2mg/kg of 0.5% plain Bupivacaine with maximal dose of 30 ml or 150 mg. The hypothesis of the study is that plasma concentration of bupivacaine after intercostal injections of 266 mg of liposomal bupivacaine will be similar to concentrations after injections of plain bupivacaine, and will remain below the toxic level threshold range of 2000-3000 ng/mL (2-3 mg/L) at which central nervous system and cardiovascular adverse events would be expected to occur. The secondary objective is to evaluate if intercostal injections of 266 mg of liposomal bupivacaine will significantly reduce opioid consumption and postsurgical pain, within the first 48 hours and up to 3 months after minimally invasive thoracic surgeries, to determine if both acute and chronic post-thoracotomy pain can be decreased by intraoperative intercostal injections of liposomal bupivacaine. Additionally, the rate of pneumonia, the rate of atrial fibrillation and length of hospital stay will be assessed as secondary outcomes after thoracic surgeries. These outcomes can be affected by the level of postoperative pain and inflammation. Significance of this study: If positive, the results of this research have the potential to significantly improve pain management after thoracoscopic surgery. Based on prior experience, prolonged analgesia after liposomal bupivacaine injection is safe, and may help reduce perioperative opioid consumption and decrease opioid related complications. It will improve patient comfort, eliminate need for indwelling neuraxial ca
Conditions Studied
Interventions
- DRUG Bupivacaine
- DRUG Exparel
Study Locations (1)
Pennsylvania
- Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-04-09 |
| Est. Completion | 2026-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03737292
The ClinicalTrials.gov registry entry for NCT03737292 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (85% lower). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine is the first listed.
NCT03737292 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03737292 about?
NCT03737292 is a clinical study titled "Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy". The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries. The specific aim of this study is to evaluate plasma concentration of bupivacaine af...
What is the current status of trial NCT03737292?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2019-04-09. Estimated completion is 2026-10.
What conditions does trial NCT03737292 study?
This clinical trial studies the following conditions: Pain, Postoperative, Pharmacokinetics.
What interventions are being tested in trial NCT03737292?
The interventions under investigation include: Bupivacaine (DRUG), Exparel (DRUG).
Who is sponsoring clinical trial NCT03737292?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03737292 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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