Liposomal Bupivacaine (Exparel) in Sarcomas

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Soft Tissue Sarcoma, Soft Tissue Tumor, Soft Tissue Tumor and/or Sarcoma

Intervention / Treatment
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* Drug: Liposomal Bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liiposomal Bupivacaine Group<br>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. | Drug: Liposomal Bupivacaine<br>* A 25 gauge or larger bore needle will be used to inject the liposomal bupivacaine at the site of operation following the prescription guidelines provided by Exparel®. The maximum dose allowable for this study is 266mg or 20 mL as indicated in the FDA package insert.<br>* Other names: Exparel;|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with peak pain scores measured by VAS less than 7 | 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. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Pain Scores during hospital stay post surgery | 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. | Up to 5 days | 
| Amount of opiate use post-operatively while the patient is in the hospital in milligram morphine equivalent (MME) | 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. | Up to 5 days | 
| Number of surgical-related infection | Number of surgical-related infection will be documented by use of Treatment Follow-Up Form and Adverse Event Log. | 6 week post surgery | 
| Average Pain Scores during hospitalization | 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. | up to 5 days | 
| Length of time in hospital | 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 | End of hospitalization (up to 30 days) | 
| Rate of approached and consented patients | The rate will be calculated with the number of participants that consented divided by the number of patients approached about the study | end of the study up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exparel, Liposomal Bupivacaine, Removal by Surgery, Pain Reduction