NCT02499159

Pain Management in Response to Exparel vs. Standard Bupivicaine

A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications. Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.

Detailed description

Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection. It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine. Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space. Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Liposomal Bupivicaine	266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.
DRUG	0.25% standard bupivicaine	standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-07-16
• Last updated: 2021-02-16
• Results posted: 2019-09-06

Locations

2 sites across 1 country: United States