Liposomal Bupivacaine (Exparel) in Sarcomas

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

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

Study Overview

• Status: Terminated
• Conditions: Soft Tissue Sarcoma; Soft Tissue Tumor; Soft Tissue Tumor and/or Sarcoma
• Intervention / Treatment: Drug: Liposomal Bupivacaine

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liiposomal Bupivacaine Group; 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; 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.; Other Names: Exparel
No Intervention: Control Group; 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?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• Exparel (bupivacaine liposomal) [prescribing information]. San Diego, CA: Pacira Pharmaceuticals Inc; August 2016
• 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.

Helpful Links

• US Centers for Disease Control and Prevention. Drug overdose deaths in the United States hit record numbers in 2014. Accessed January, 30 2018.
• North Carolina Medical Board. Stop Act prescribing limits in effect January 1, 2018. Accessed January, 30 2018.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): June 11, 2019
• Study Completion (Actual): June 11, 2019

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Liposomal Bupivacaine; Exparel; Pain Reduction; Removal by Surgery
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Sarcoma; Soft Tissue Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB00050365; WFBCCC 71118 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after de-identification.
• IPD Sharing Time Frame: Immediately following publication, no end date
• IPD Sharing Access Criteria: Anyone who wishes to access the data; Any purpose. Data available indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No