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Liposomal Bupivacaine (Exparel) in Sarcomas

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ClinicalTrials.gov Identifier: NCT03867188
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Soft Tissue Tumor Soft Tissue Tumor and/or Sarcoma Drug: Liposomal Bupivacaine Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Use of Liposomal Bupivacaine (Exparel) in Soft Tissue Sarcoma Resection
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


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 Name: 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.



Primary Outcome Measures :
  1. Number of participants with peak pain scores measured by VAS less than 7 [ Time Frame: Up to 24 hours ]
    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 :
  1. Peak Pain Scores during hospital stay post surgery [ Time Frame: Up to 5 days ]
    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.

  2. Amount of opiate use post-operatively while the patient is in the hospital in milligram morphine equivalent (MME) [ Time Frame: Up to 5 days ]
    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.

  3. Number of surgical-related infection [ Time Frame: 6 week post surgery ]
    Number of surgical-related infection will be documented by use of Treatment Follow-Up Form and Adverse Event Log.

  4. Average Pain Scores during hospitalization [ Time Frame: up to 5 days ]
    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.

  5. Length of time in hospital [ Time Frame: End of hospitalization (up to 30 days) ]
    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

  6. Rate of approached and consented patients [ Time Frame: end of the study up to 2 years ]
    The rate will be calculated with the number of participants that consented divided by the number of patients approached about the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (either directly or via a legally authorized representative)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867188


Contacts
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Contact: Debra Bullard 336-716-9877 dbullard@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Debra Bullard    336-716-9877    dbullard@wakehealth.edu   
Principal Investigator: Cynthia L Emory, MD         
Sub-Investigator: Carl Edge, B.S.         
Sub-Investigator: Donald J Scholten, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Cynthia L Emory, MD Wake Forest University Health Sciences

Additional Information:
Publications:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03867188     History of Changes
Other Study ID Numbers: IRB00050365
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after de-identification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Immediately following publication, no end date
Access Criteria: Anyone who wishes to access the data; Any purpose. Data available indefinitely.

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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

Keywords provided by Wake Forest University Health Sciences:
Exparel
Liposomal Bupivacaine
Removal by Surgery
Pain Reduction

Additional relevant MeSH terms:
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Sarcoma
Soft Tissue Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents