Liposomal Bupivacaine (Exparel) in Sarcomas

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03867188
• Other study ID #: IRB00050365
• Secondary ID: WFBCCC 71118
• Status: Terminated
• Phase: Early Phase 1
• Start date: January 14, 2019
• Est. completion date: June 11, 2019

Study information

• Verified date: February 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 11, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Neoplasms
• Soft Tissue Sarcoma
• Soft Tissue Tumor
• Soft Tissue Tumor and/or Sarcoma

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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

External Links

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