Clinical trial NCT03867188: Liposomal Bupivacaine (Exparel) in Sarcomas
Official title: The Use of Liposomal Bupivacaine (Exparel) in Soft Tissue Sarcoma Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Soft Tissue Sarcoma
Soft Tissue Tumor
Soft Tissue Tumor and/or Sarcoma
Keywords: Exparel
Liposomal Bupivacaine
Removal by Surgery
Pain Reduction
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with peak pain scores measured by VAS less than 7
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Peak Pain Scores during hospital stay post surgery
timeFrame: Up to 5 days
measure: Amount of opiate use post-operatively while the patient is in the hospital in milligram morphine equivalent (MME)
timeFrame: Up to 5 days
measure: Number of surgical-related infection
timeFrame: 6 week post surgery
measure: Average Pain Scores during hospitalization
timeFrame: up to 5 days
measure: Length of time in hospital
timeFrame: End of hospitalization (up to 30 days)
measure: Rate of approached and consented patients
timeFrame: end of the study up to 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Cynthia L Emory, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baxter R, Bramlett K, Onel E, Daniels S. Impact of local administration of liposome bupivacaine for postsurgical analgesia on wound healing: a review of data from ten prospective, controlled clinical studies. Clin Ther. 2013 Mar;35(3):312-320.e5. doi: 10.1016/j.clinthera.2013.02.005. Epub 2013 Mar 1.
citation: Exparel (bupivacaine liposomal) [prescribing information]. San Diego, CA: Pacira Pharmaceuticals Inc; August 2016
citation: Ranawat AS, Ranawat CS. Pain management and accelerated rehabilitation for total hip and total knee arthroplasty. J Arthroplasty. 2007 Oct;22(7 Suppl 3):12-5. doi: 10.1016/j.arth.2007.05.040.
citation: Snyder MA, Scheuerman CM, Gregg JL, Ruhnke CJ, Eten K. Improving total knee arthroplasty perioperative pain management using a periarticular injection with bupivacaine liposomal suspension. Arthroplast Today. 2016 Jan 11;2(1):37-42. doi: 10.1016/j.artd.2015.05.005. eCollection 2016 Mar.