NCT03737292 Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
| NCT ID | NCT03737292 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2019-04-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2019-04-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 catheters and risks associated with them.
Eligibility Criteria
Inclusion Criteria: 1\. Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including but not limited to: 1. VATS wedge resection /segmentectomy 2. VATS lobectomy. 3. Robot assisted thoracoscopic wedge resection/segmentectomy. 4. Robot assisted thoracoscopic lobectomy procedures. Exclusion Criteria: 1. Patients under18 years of age 2. Patients weighing less than 48 kg 3. Pregnant and lactating females will be excluded from the trial 4. Patients preoperatively taking narcotics for chronic pain in proximity to surgical site 5. Patients with previous ipsilateral thoracic surgery 6. Patients undergoing pleurectomy/mechanical pleurodesis. 7. Patients with high likelihood of conversion from thoracoscopic procedure to open thoracotomy as determined by an operating surgeon 8. Patients with pre-existing painful conditions (CRIPS, fibromyalgia, neuropathy) 9. Patients unable to reliably communicate pain scores such as patients with dementia, alterations in mental status 10. Patients with hypersensitivity to local anesthetics and pain medications used in the study 11. Patients with previous thoracic spine surgeries 12. Patients with increased creatinine (over 1.5mg/dl) 13. Patients with liver dysfunction 14. Non-English speaking patients
Contact & Investigator
Zoulfira Nisnevitch-Savarese, MD
PRINCIPAL INVESTIGATOR
Penn State Hershey College of Medicine
Frequently Asked Questions
Who can join the NCT03737292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03737292 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03737292 currently recruiting?
Yes, NCT03737292 is actively recruiting participants. Contact the research team at znisnevitchsavarese@pennstatehealth.psu.edu for enrollment information.
Where is the NCT03737292 trial being conducted?
This trial is being conducted at Hershey, United States.
Who is sponsoring the NCT03737292 clinical trial?
NCT03737292 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Zoulfira Nisnevitch-Savarese, MD at Penn State Hershey College of Medicine. The trial plans to enroll 40 participants.