Liposomal Bupivacaine (Exparel) in Sarcomas

Wake Forest University (WFU)

Status and phase: Terminated; Early Phase 1

Conditions: Soft Tissue Sarcoma; Soft Tissue Tumor; Soft Tissue Tumor and/or Sarcoma

Treatments: Drug: Liposomal Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03867188

IRB00050365

WFBCCC 71118 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Liiposomal Bupivacaine Group

Experimental group

Description:

Qualified participants with a soft tissue sarcoma of the thigh will be given the alternative protocol utilizing liposomal bupivacaine (Exparel®). The alternative protocol will utilize general or spinal anesthesia, but will also include the use of intraoperative liposomal bupivacaine instead of a regional nerve block.

Treatment:

Drug: Liposomal Bupivacaine

Control Group

No Intervention group

Description:

A retrospective control group will be assembled from electronic medical records of 3 patients who underwent resection of a soft tissue sarcoma of the thigh and will be accessed and analyzed for the variable of interest.