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Soft Tissue SarcomaEarly Phase 1NCT03867188

Liposomal Bupivacaine (Exparel) in Sarcomas

A Early Phase 1 study testing Liposomal Bupivacaine in people with Soft Tissue Sarcoma and Soft Tissue Tumor, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Liposomal Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
14 Jan 2019to 11 Jun 2019
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
Liposomal Bupivacaine
Keywords
Exparel, Liposomal Bupivacaine, Removal by Surgery, Pain Reduction
Medical subject headings
Sarcoma, Soft Tissue Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal BupivacaineDrug

    Also called Exparel

    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.

Study groups in NCT03867188
Study groupRoleWhat they receive
Liiposomal Bupivacaine GroupExperimentalQualified 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.
Receives: Drug: Liposomal Bupivacaine
Control GroupNo interventionA 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 hours

Secondary outcomes (6)

  1. 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.

    Measured: Up to 5 days

  2. 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.

    Measured: Up to 5 days

  3. Number of surgical-related infection

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

    Measured: 6 week post surgery

  4. 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.

    Measured: up to 5 days

  5. 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

    Measured: End of hospitalization (up to 30 days)

  6. 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

    Measured: end of the study up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start14 Jan 2019
  3. Primary completion11 Jun 2019
  4. Study completion11 Jun 2019

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03867188
Sponsor's protocol ID
IRB00050365
Other IDs
WFBCCC 71118
Status last verified
Feb 2022
First submitted
6 Mar 2019
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after de-identification.

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.

    PubMed 23453403

  • 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.

    PubMed 17919586

  • 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.

    PubMed 28326395

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Liposomal Bupivacaine in people with Soft Tissue Sarcoma and Soft Tissue Tumor, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Enrollment of eligible subjects, delays due to the COVID-19 Virus, and lack of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with peak pain scores measured by VAS less than 7 (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03867188, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.

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