Benign NeoplasmPhase 4NCT05082441
Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Benign Neoplasm, run by Samaritan Health Services at 1 site in United States.
Trial summary
Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Benign Neoplasm
- What is being tested?
- Liposomal bupivacaine and Bupivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All benign soft tissue tumors greater than one cubic cm
- Adults 18 years and older
Who cannot join
- Pregnant females
- Women who are breastfeeding
- Less than 18 years old
- Malignant tumors
- Tumors smaller than 1 cubic cm
- Allergy to Exparel
Show all 10Show fewer
- Patients who are opioid dependent defined as patients on a long acting narcotic or who take more than 30 morphine equivalents per day
- Allergy to amide anesthetics
- bone tumors
- Patients unable to comply with the study standards and follow up
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
Jared Sanderford, DO, 541-768-5111, jareds@samhealth.org
Nicolas Tedesco, DO, 541-768-4811, ntedesco@samhealth.org
About this study
Official title: Efficacy of Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection: A Randomized Controlled Trial
Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.
Read the detailed description
Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.
Patients will be randomly assigned Exparel or Bupivacaine HCL intraoperatively during the tumor resection. The amount administered is based on the size of wound after tumor resection. The patients are then provided a pain diary in which they record the amount of pain medications taken, VAS pain scores, and musculoskeletal and tumor society score (MSTS) for the first week postoperatively.
The study will end once 140 patients have been enrolled. Data will be analyzed comparing morphine equivalents, pain scores, and functional scores between the groups.
- Conditions
- Benign Neoplasm
- Being tested
- Liposomal bupivacaine, Bupivacaine Hydrochloride
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Experimental
Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine
Bupivacaine HydrochlorideDrug
Also called Control
plain bupivacaine subcutaneous injection as standard of care control
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Exparel group Receives: Drug: Liposomal bupivacaine |
| control | Active comparator | plain bupivacaine Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use
Amount of morphine equivalents used for postoperative pain control
Measured: first 7 days postoperatively
Secondary outcomes (1)
Pain Score
VAS pain score
Measured: First 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samaritan Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082441
- Sponsor's protocol ID
- IRB20-050
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05082441
- Acronym / sponsor ID
- IRB20-050
- Conditions
- Benign Neoplasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Samaritan Health ServicesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.
Detailed description
Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.
Patients will be randomly assigned Exparel or Bupivacaine HCL intraoperatively during the tumor resection. The amount administered is based on the size of wound after tumor resection. The patients are then provided a pain diary in which they record the amount of pain medications taken, VAS pain scores, and musculoskeletal and tumor society score (MSTS) for the first week postoperatively.
The study will end once 140 patients have been enrolled. Data will be analyzed comparing morphine equivalents, pain scores, and functional scores between the groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: Liposomal bupivacaineExparel group |
| control | Active comparator | Drug: Bupivacaine Hydrochlorideplain bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All benign soft tissue tumors greater than one cubic cm
- Adults 18 years and older
Key exclusion criteria (10 listed)
- Pregnant females
- Women who are breastfeeding
- Less than 18 years old
- Malignant tumors
- Tumors smaller than 1 cubic cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: ExperimentalExparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine | Drug | experimental |
| Bupivacaine HydrochlorideAlso: Controlplain bupivacaine subcutaneous injection as standard of care control | Drug | control |
Primary outcome
Opioid Use
Time frame: first 7 days postoperatively
Amount of morphine equivalents used for postoperative pain control
1 secondary outcome
Pain Score
Time frame: First 7 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Benign Neoplasm, run by Samaritan Health Services 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Oct 2021. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use (time frame: first 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.