NCT03867188

Liposomal Bupivacaine (Exparel) in Sarcomas

The Use of Liposomal Bupivacaine (Exparel) in Soft Tissue Sarcoma Resection

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to study a medication called liposomal bupivacaine (EXPAREL®). Study doctors want to see if it is safe, if it can reduce pain after surgery, and the study doctor want to study its use after the removal a soft tissue tumor called a sarcoma

Detailed description

The hypothesis for this project is that using liposomal bupivacaine will reduce patients' morphine equivalent usage postoperatively while maintaining similar pain scores and lengths of stay when compared to patients that did not receive intraoperative liposomal bupivacaine. Thus, if the use of liposomal bupivacaine proves to aid in pain control and the reduction of initial opiate use following soft tissue sarcoma resection, it could be reasonably suggested that liposomal bupivacaine become incorporated into a multimodal form of pain management following soft tissue sarcoma resection. These results are expected to have a significant positive impact; allowing for a reduction in narcotic pain medication usage and its associated side effects while decreasing health care expenditures.

Conditions

• Soft Tissue Sarcoma
• Soft Tissue Tumor
• Soft Tissue Tumor and/or Sarcoma

Interventions

Type	Name	Description
DRUG	Liposomal Bupivacaine	A 25 gauge or larger bore needle will be used to inject the liposomal bupivacaine at the site of operation following the prescription guidelines provided by Exparel®. The maximum dose allowable for this study is 266mg or 20 mL as indicated in the FDA package insert.

Timeline

• Start date: 2019-01-14
• Primary completion: 2019-06-11
• Completion: 2019-06-11
• First posted: 2019-03-07
• Last updated: 2023-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study