CREST SyndromePhase 2/3NCT02374320
Exparel as a Nerve Block for Severe Hand Pain
A Phase 2/3 study testing liposomal bupivacaine in people with CREST Syndrome and Peripheral Vascular Disease, run by Jose Soberon, MD at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CREST Syndrome, Peripheral Vascular Disease, Raynaud Disease
- What is being tested?
- liposomal bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- American Society of Anesthesiologists (ASA) status I-IV
Who cannot join
- True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine
- Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted)
- Pregnancy
- Severe hepatic impairment
- Evidence of infection at or near the proposed needle insertion site
- Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the PI and/or designee
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
About this study
Official title: Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.
- Being tested
- liposomal bupivacaine
- Medical subject headings
- CREST Syndrome, Peripheral Vascular Diseases, Raynaud Disease, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal bupivacaineDrug
injected as an axillary block
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Experimental | 20 mL liposomal bupivacaine injected once Receives: Drug: liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial and Ulnar Arterial Diameter
Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.
Measured: 1 hour
Secondary outcomes (1)
Pain Measured by Numerical Rating Scale
Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CREST SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Soberon, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Soberon, MD, Ochsner Health System
- Investigators
- Jose Soberon, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374320
- Sponsor's protocol ID
- 2014.155.C
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2015
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine
- ClinicalTrials.gov ID
- NCT02374320
- Acronym / sponsor ID
- 2014.155.C
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving institution
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Jose Soberon, MDUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exparel | Experimental | Drug: liposomal bupivacaine20 mL liposomal bupivacaine injected once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) status I-IV
Key exclusion criteria (6 listed)
- True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine
- Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted)
- Pregnancy
- Severe hepatic impairment
- Evidence of infection at or near the proposed needle insertion site
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 bupivacaineinjected as an axillary block | Drug | Exparel |
Primary outcome
Radial and Ulnar Arterial Diameter
Time frame: 1 hour
Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.
1 secondary outcome
Pain Measured by Numerical Rating Scale
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jose Soberon, MD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing liposomal bupivacaine in people with CREST Syndrome and Peripheral Vascular Disease, run by Jose Soberon, MD 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 1 inclusion and 6 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 21 May 2024. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Radial and Ulnar Arterial Diameter (time frame: 1 hour). 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 21 May 2024.