Musculoskeletal DiseasesPhase 2NCT05355597
"The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors"
A Phase 2 study testing Exparel Injectable Product and Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine) in people with Musculoskeletal Diseases and Soft Tissue Mass, run by Atlantic Health System at 1 site in United States.
Trial summary
The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases, Soft Tissue Mass
- What is being tested?
- Exparel Injectable Product and Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2021to 24 Mar 2025
- Phase
- Phase 2
- 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
- All primary soft tissue tumors
- Any adult patient (over 18 years old) with a soft tissue tumor confirmed with advanced imaging.
- Two different study groups will be examined:
- Those patients undergoing resection of their soft tissue tumor intraoperatively injected with Exparel
- Those patients undergoing resection of their soft tissue tumor intraoperatively injected with the cocktail.
- Those two groups will be further stratified by anatomic location; Upper vs lower extremity, size; tumors ≥ 10cm, tumors ≥ 5cm, tumors < 5cm, and depth; superficial vs deep.
Who cannot join
- Pediatric Patients
- Patients without soft tissue tumors
- Tylenol or oxycodone allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown Medical Center
Morristown, New Jersey, 07960
About this study
The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.
Read the detailed description
In recent years, there has been a substantial push to create a post-surgical protocol consisting of multimodal analgesia across multiple surgical subspecialties to decrease narcotic consumption and cost1. The negative side effects of narcotics and their addiction potential are well understood.
One of the modes of analgesia currently in use to mitigate surgical pain is some form of local anesthetic. Increasing the duration of analgesia has been sought after since its inception. Subsequently, longer acting anesthetics like bupivacaine have been implemented as well as supplementing their use with other drugs, such as epinephrine, to increase their effect duration and overall efficacy2. This has led to the development of Liposomal Bupivicaine or Exparel (TM, Parsippany NJ etc.) Exparel works by infusing liposomes in the administration of the long acting local analgesic which entrap the biologically active drug and slowly release it over a period of 72-96 hours 3-4. Thus, post-operative pain can be managed via direct injection of the drug at the surgical site with upwards to four days of pain relief.
Exparel has been studied extensively in the surgical literature; although within orthopedics, it has been primarily in regard to arthroplasty5. There has yet to be a study to illicit the best form of post-operative pain control in the world of orthopedic oncology, specifically in soft tissue tumors.
The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.
- Conditions
- Musculoskeletal Diseases, Soft Tissue Mass
- Being tested
- Exparel Injectable Product, Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel Injectable ProductDrug
Both drugs have same desired effect. Will be injected intra-operatively while subjects are under anesthesia to alleviate significant post-operative pain.
Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)Drug
Same desired effect as Exparel but different mechanism of action. Will be injected intra-operatively while subjects are under anesthesia to alleviate significant post-operative pain.
| Study group | Role | What they receive |
|---|---|---|
| Exparel Group | Experimental | 70 subjects will receive Exparel Receives: Drug: Exparel Injectable Product |
| Multi-Drug Cocktail Group | Experimental | 70 subjects will receive a Multi-drug Cocktail Receives: Drug: Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Outcomes
Pain will be recorded on a sheet for each patient. Self-reported, patient will describe pain each day on a scale of 1-10 (10 being the worst)
Measured: 14 days
Secondary outcomes (1)
Medication Consumption
Patient will self-report how much medication he or she took each day post-operatively.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start27 Jan 2021
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Why it stopped: Physician left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total of 140 subjects are recruited. Group A Receives one drug (70) and Group B receives the other drug (70)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Wittig, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355597
- Sponsor's protocol ID
- 1429450
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with other researchers, but we do anticipate publishing the results in a journal.
Publications
Kelly MA. Current Postoperative Pain Management Protocols Contribute to the Opioid Epidemic in the United States. Am J Orthop (Belle Mead NJ). 2015 Oct;44(10 Suppl):S5-8.
PubMed 26447431Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
PubMed 22285545Ranade VV. Drug delivery systems. 1. site-specific drug delivery using liposomes as carriers. J Clin Pharmacol. 1989 Aug;29(8):685-94. doi: 10.1002/j.1552-4604.1989.tb03403.x.
PubMed 2674208Barrington JW. Efficacy of Periarticular Injection With a Long-Acting Local Analgesic in Joint Arthroplasty. Am J Orthop (Belle Mead NJ). 2015 Oct;44(10 Suppl):S13-6.
PubMed 26447426
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors"
- ClinicalTrials.gov ID
- NCT05355597
- Acronym / sponsor ID
- 1429450
- Conditions
- Musculoskeletal Diseases, Soft Tissue Mass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Physician left institution
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 2 May 2022 (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.
The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.
Detailed description
In recent years, there has been a substantial push to create a post-surgical protocol consisting of multimodal analgesia across multiple surgical subspecialties to decrease narcotic consumption and cost1. The negative side effects of narcotics and their addiction potential are well understood.
One of the modes of analgesia currently in use to mitigate surgical pain is some form of local anesthetic. Increasing the duration of analgesia has been sought after since its inception. Subsequently, longer acting anesthetics like bupivacaine have been implemented as well as supplementing their use with other drugs, such as epinephrine, to increase their effect duration and overall efficacy2. This has led to the development of Liposomal Bupivicaine or Exparel (TM, Parsippany NJ etc.) Exparel works by infusing liposomes in the administration of the long acting local analgesic which entrap the biologically active drug and slowly release it over a period of 72-96 hours 3-4. Thus, post-operative pain can be managed via direct injection of the drug at the surgical site with upwards to four days of pain relief.
Exparel has been studied extensively in the surgical literature; although within orthopedics, it has been primarily in regard to arthroplasty5. There has yet to be a study to illicit the best form of post-operative pain control in the world of orthopedic oncology, specifically in soft tissue tumors.
The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Total of 140 subjects are recruited. Group A Receives one drug (70) and Group B receives the other drug (70)
| Arm | Type | Receives |
|---|---|---|
| Exparel Group | Experimental | Drug: Exparel Injectable Product70 subjects will receive Exparel |
| Multi-Drug Cocktail Group | Experimental | Drug: Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)70 subjects will receive a Multi-drug Cocktail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All primary soft tissue tumors
- Any adult patient (over 18 years old) with a soft tissue tumor confirmed with advanced imaging.
- Those patients undergoing resection of their soft tissue tumor intraoperatively injected with Exparel
- Those patients undergoing resection of their soft tissue tumor intraoperatively injected with the cocktail.
- Those two groups will be further stratified by anatomic location; Upper vs lower extremity, size; tumors ≥ 10cm, tumors ≥ 5cm, tumors < 5cm, and depth; superficial vs deep.
Key exclusion criteria (3 listed)
- Pediatric Patients
- Patients without soft tissue tumors
- Tylenol or oxycodone allergy
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 |
|---|---|---|
| Exparel Injectable ProductBoth drugs have same desired effect. Will be injected intra-operatively while subjects are under anesthesia to alleviate significant post-operative pain. | Drug | Exparel Group |
| Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine)Same desired effect as Exparel but different mechanism of action. Will be injected intra-operatively while subjects are under anesthesia to alleviate significant post-operative pain. | Drug | Multi-Drug Cocktail Group |
Primary outcome
Pain Outcomes
Time frame: 14 days
Pain will be recorded on a sheet for each patient. Self-reported, patient will describe pain each day on a scale of 1-10 (10 being the worst)
1 secondary outcome
Medication Consumption
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Physician left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Results publication: PubMed 26447431Kelly MA. Current Postoperative Pain Management Protocols Contribute to the Opioid Epidemic in the United States. Am J Orthop (Belle Mead NJ). 2015 Oct;44(10 Suppl):S5-8.
- Results publication: PubMed 22285545Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
- Results publication: PubMed 2674208Ranade VV. Drug delivery systems. 1. site-specific drug delivery using liposomes as carriers. J Clin Pharmacol. 1989 Aug;29(8):685-94. doi: 10.1002/j.1552-4604.1989.tb03403.x.
- Results publication: PubMed 26447426Barrington JW. Efficacy of Periarticular Injection With a Long-Acting Local Analgesic in Joint Arthroplasty. Am J Orthop (Belle Mead NJ). 2015 Oct;44(10 Suppl):S13-6.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with other researchers, but we do anticipate publishing the results in a journal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exparel Injectable Product and Multi-Drug Cocktail (Ropivicaine, Epinephrine, Ketolorac, Clonidine) in people with Musculoskeletal Diseases and Soft Tissue Mass, run by Atlantic Health System 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 6 inclusion and 3 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 9 Apr 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Physician left institution). 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?
Pain Outcomes (time frame: 14 days). 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 NCT05355597, 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 9 Apr 2025.