Liposomal Bupivacaine (Exparel) in Sarcomas

Early Phase 1

Terminated

• Conditions: Soft Tissue Sarcoma; Soft Tissue Tumor; Soft Tissue Tumor and/or Sarcoma
• Interventions: Drug: Liposomal Bupivacaine

• Registration Number: NCT03867188
• Lead Sponsor: Wake Forest University Health Sciences

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 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.

Study Timeline

• Study Start: 2019-01-14
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Primary Completion: 2019-06-11
• Study Completion: 2019-06-11
• Status Verified: 2022-02
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liiposomal Bupivacaine Group	Liposomal Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with peak pain scores measured by VAS less than 7	Up to 24 hours	Feasibility of Exparel for post surgical pain management in soft-tissue sarcoma surgeries of the thigh will be defined as peak pain score measured by VAS (Visual Analogue Scale) less than 7. VAS scores range 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.

Secondary Outcome Measures

Name	Time	Method
Number of surgical-related infection	6 week post surgery	Number of surgical-related infection will be documented by use of Treatment Follow-Up Form and Adverse Event Log.
Amount of opiate use post-operatively while the patient is in the hospital in milligram morphine equivalent (MME)	Up to 5 days	The opioid medications that the subject uses will be recorded and the data regarding total narcotic usage will be converted to MME to maintain a standard unit for the study.
Average Pain Scores during hospitalization	up to 5 days	Average pain scores will be measured by VAS (Visual Analogue Scale). VAS ranges 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.
Length of time in hospital	End of hospitalization (up to 30 days)	The unit of time used to record length of stay will be days. Defined as the time from entry into the post anesthesia care unit (PACU) to discharge
Rate of approached and consented patients	end of the study up to 2 years	The rate will be calculated with the number of participants that consented divided by the number of patients approached about the study
Peak Pain Scores during hospital stay post surgery	Up to 5 days	Peak pain scores will be measured by VAS (Visual Analogue Scale) which is printed on the Post-Operative Pain and Medication Administration questionnaire. VAS ranges 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States