Liposomal Bupivacaine (Exparel) in Sarcomas



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:January 14, 2019
End Date:January 2021
Contact:Debra Bullard
Email:dbullard@wakehealth.edu
Phone:336-716-9877

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

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

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.

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 (either directly or via a legally authorized representative)

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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Cynthia L Emory, MD
Phone: 336-716-9877
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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