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Liposomal Bupivacaine (Exparel) in Sarcomas

Primary Purpose

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

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Liposomal Bupivacaine

About this trial

This is an interventional supportive care trial for Soft Tissue Sarcoma focused on measuring Exparel, Liposomal Bupivacaine, Removal by Surgery, Pain Reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Liiposomal Bupivacaine Group

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Number of surgical-related infection

Number of surgical-related infection will be documented by use of Treatment Follow-Up Form and Adverse Event Log.

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.

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

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

Full Information

NCT ID

NCT03867188

First Posted

March 6, 2019

Last Updated

March 17, 2023

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03867188

Brief Title

Liposomal Bupivacaine (Exparel) in Sarcomas

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Enrollment of eligible subjects, delays due to the COVID-19 Virus, and lack of funding

Study Start Date

January 14, 2019 (Actual)

Primary Completion Date

June 11, 2019 (Actual)

Study Completion Date

June 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Exparel, Liposomal Bupivacaine, Removal by Surgery, Pain Reduction

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liiposomal Bupivacaine Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Liposomal Bupivacaine

Other Intervention Name(s)

Exparel

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants with peak pain scores measured by VAS less than 7

Description

Time Frame

Up to 24 hours

Secondary Outcome Measure Information:

Title

Peak Pain Scores during hospital stay post surgery

Description

Time Frame

Up to 5 days

Title

Amount of opiate use post-operatively while the patient is in the hospital in milligram morphine equivalent (MME)

Description

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.

Time Frame

Up to 5 days

Title

Number of surgical-related infection

Description

Number of surgical-related infection will be documented by use of Treatment Follow-Up Form and Adverse Event Log.

Time Frame

6 week post surgery

Title

Average Pain Scores during hospitalization

Description

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.

Time Frame

up to 5 days

Title

Length of time in hospital

Description

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

Time Frame

End of hospitalization (up to 30 days)

Title

Rate of approached and consented patients

Description

The rate will be calculated with the number of participants that consented divided by the number of patients approached about the study

Time Frame

end of the study up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cynthia L Emory, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

23453403

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

17919586

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.

Results Reference

background

PubMed Identifier

28326395

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.

Results Reference

background

Links:

URL

http://www.cdc.gov/drugoverdose/epidemic/

Description

US Centers for Disease Control and Prevention. Drug overdose deaths in the United States hit record numbers in 2014. Accessed January, 30 2018.

URL

https://www.ncmedboard.org/resources-information/professional-resources/publications/forum-newsletter/notice/stop-act-prescribing-limits-in-effect-jan

Description

North Carolina Medical Board. Stop Act prescribing limits in effect January 1, 2018. Accessed January, 30 2018.

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Liposomal Bupivacaine (Exparel) in Sarcomas

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