Clinical trial · Interventional
Liposomal Bupivacaine (Exparel) in Sarcomas
The Use of Liposomal Bupivacaine (Exparel) in Soft Tissue Sarcoma Resection
NCT03867188CI-TRIAL-00064887terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment of eligible subjects, delays due to the COVID-19 Virus, and lack of funding
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Soft Tissue Tumor | Soft Tissue Neoplasm | ALIAS | 0.90 |
| Soft Tissue Tumor and/or Sarcoma | Sarcoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal Bupivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Liiposomal Bupivacaine 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.
- interventionNames
- Drug: Liposomal Bupivacaine
- type
- NO_INTERVENTION
- label
- Control 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.
Primary outcomes (1)
- measure
- Number of participants with peak pain scores measured by VAS less than 7
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDBaxter 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. PMID 23453403
- BACKGROUNDExparel (bupivacaine liposomal) [prescribing information]. San Diego, CA: Pacira Pharmaceuticals Inc; August 2016
- BACKGROUNDRanawat 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. PMID 17919586
- BACKGROUNDSnyder 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. PMID 28326395