Status:
TERMINATED
Liposomal Bupivacaine (Exparel) in Sarcomas
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Soft Tissue Sarcoma
Soft Tissue Tumor
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 t...
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 compa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03867188
Start Date
January 14 2019
End Date
June 11 2019
Last Update
March 22 2023
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157