Recruiting

Liposomal Bupivacaine vs. Bupivacaine

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT03737292

Conditions

Pain, Postoperative

Pharmacokinetics

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exparel

Bupivacaine

Study Details

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.

Conditions

Pain, Postoperative

Pharmacokinetics

Study ID

NCT03737292

Start date

Apr 9, 2019

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exparel

Intercostal injection of 266mg of Exparel diluted to 30 ml.

active comparator: Bupivacaine

Intercostal injection of 0.5% Bupivacaine 2 mg/kg dose diluted to 30 ml.

Interventions

Exparel

The intercostal blocks will be performed at several levels corresponding to the incisions and chest tube insertion sites + two levels above and two levels below the incisions. On average, 5-6 intercostal spaces will be injected with 4-5 ml of local anesthetic at each level.

Bupivacaine

The intercostal injections of 0.5% Bupivacaine 2 mg/kg dose diluted to 30 ml total will be performed at several levels corresponding to the incisions and chest tube insertion sites + two levels above and two levels below the incisions.

Primary outcome measure

  • Plasma concentration of bupivacaine [ Time Frame: 0.5, 1, 2, 4, 8, 12, 24, 32, 48, 72 hours after intraoperative multiple level intercostal injections. ]

Central Contacts and Locations

Central contacts

Zoulfira Nisnevitch-Savarese, MD

717-531-4264znisnevitchsavarese@pennstatehealth.psu.edu

Christopher Cowart, MD

717-531-4264ccowart@pennstatehealth.psu.edu

Locations

Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Zoulfira Nisnevitch-Savarese, MD

7175310003znisnevitchsavarese@pennstatehealth.psu.edu

Ruth Jarbadan, BS

717-531-6135njarbadan@pennstatehealth.psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-06-12.