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Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Minor Primary and study completion dates: Oct 2026 to Dec 2026
    • Site contact updated
    v12
  2. Notable Primary and study completion dates: Oct 2025 to Oct 2026v11
  3. Notable Primary and study completion dates: Oct 2024 to Oct 2025v10
  4. Notable Primary and study completion dates: Oct 2023 to Oct 2024v9
  5. Minor Site contact updatedv8
Show 6 earlier versionsHide 6 earlier versions
  1. Notable Trial status: Suspended to Recruiting
    • Primary completion date: Mar 2021 to Oct 2023
    • Study completion date: Jun 2021 to Oct 2023
    • Site details revised
    v7
  2. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Temporarily suspended due to Pandemic.
    • Site details revised
    v6
  3. Minor Start date changed from estimate of Apr 2019 to Apr 9, 2019v5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Mar 2019 to Apr 2019
    v4
  5. Minor Primary completion date: Feb 2021 to Mar 2021
    • Start date: Feb 2019 to Mar 2019
    v3
  6. Minor Study description shortened, about 1 wordv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 catheters and risks associated with them.
Trial Details
NCT Number NCT03737292
Lead Sponsor Milton S. Hershey Medical Center
Conditions
(from sponsor)
Pain, Postoperative, Pharmacokinetics
Related terms Postoperative Pain
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov