Comparing liposomal bupivacaine and plain bupivacaine for pain management after thoracoscopic surgery

Comparison of Plasma Concentration And Efficacy Of Liposomal Bupivacaine And Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy

This study is testing whether a newer form of bupivacaine can help manage pain after thoracoscopic surgery better and safely compared to the regular version.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (other)
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT03737292 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics of liposomal bupivacaine (Exparel) compared to plain bupivacaine after intercostal injections for pain control during and after thoracoscopic surgeries. It aims to assess plasma concentrations of bupivacaine following the administration of 266 mg of liposomal bupivacaine versus 2 mg/kg of plain bupivacaine, ensuring that levels remain below toxic thresholds. The study also investigates the safety profile of liposomal bupivacaine in this context, as its use in intercostal injections has not been extensively studied. By analyzing these parameters, the research seeks to provide insights into the efficacy and safety of this newer formulation.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old undergoing minimally invasive thoracic surgeries such as VATS lobectomy or segmentectomy.

Not a fit: Patients with chronic pain conditions, previous thoracic surgeries, or those unable to communicate pain scores may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing thoracoscopic surgeries.

How similar studies have performed: While studies on liposomal bupivacaine have shown promise in other surgical contexts, this specific application in thoracoscopic surgery is relatively novel.

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

Where this trial is running

Hershey, Pennsylvania

• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Zoulfira Nisnevitch-Savarese, MD — Penn State Hershey College of Medicine
• Study coordinator: Zoulfira Nisnevitch-Savarese, MD

Conditions: Pain, Postoperative, Pharmacokinetics