Liposomal Bupivacaine (Exparel) in Sarcomas

• Status: Terminated
• Trial end date: 2019-06-11
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Patients with a soft tissue sarcoma of the thigh

• Must have sufficient health to withstand the physical demands of surgery

• ≥ 18 years old

• ECOG performance status of ≤ 2

• Ability to understand and the willingness to sign an IRB-approved informed consent document

Exclusion Criteria:

• History of clinically significant medical conditions including: Cardiovascular: Atrial Fibrillation, Ventricular Fibrillation, Significant Coronary Artery Disease. Hepatic: Viral or Autoimmune Hepatitis, Cirrhosis of the Liver, Liver Metabolism Disorders. Renal: Any form of renal impairment. EXPAREL® is cleared by the kidneys, thus any form of renal impairment could lead to an adverse reaction.

• Medical condition(s) or concurrent surgery that may have required analgesic treatment in the postoperative period for pain that was not strictly related to the study surgery.

• Any clinically significant event or condition discovered during surgery that may have complicated the patient's post surgical course such as vascular or nerve involvement that was unknown before surgery.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal bupivacaine.

• Pregnant women are excluded from this study because EXPAREL has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with EXPAREL, breastfeeding should be discontinued if the mother is treated with EXPAREL.