Hand InjuriesPhase 4NCT02058303
Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery
A Phase 4 study testing Exparel Forearm block and Bupivacaine supraclavicular block in people with Hand Injuries and Wrist Injuries, run by Jose Soberon, MD at 1 site in United States.
Trial summary
The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries, Wrist Injuries, Finger Injuries
- What is being tested?
- Exparel Forearm block and Bupivacaine supraclavicular block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients 18 years or older having hand, wrist, or finger surgery
- ability to understand and provide informed consent
- American Society of Anesthesiologists status I-III
- presence of a responsible adult caregiver for 48-72 hours after surgery
Who cannot join
- patient refusal or inability to provide informed consent
- true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol
- pregnancy
- hepatic or renal failure
- evidence of infection at or near the proposed needle insertion site
- any sensorimotor deficit of the upper extremity
Show all 10Show fewer
- BMI greater than or equal to 35
- uncontrolled or severe pulmonary disease
- anticoagulant use (not aspirin or non-steroidal anti-inflammatories)
- chronic pain patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
About this study
Official title: Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery
The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.
- Conditions
- Hand Injuries, Wrist Injuries, Finger Injuries
- Being tested
- Exparel Forearm block, Bupivacaine supraclavicular block
- Keywords
- hand surgery, wrist surgery, finger surgery, anesthesia, regional anesthesia, postoperative pain
- Medical subject headings
- Hand Injuries, Wrist Injuries, Finger Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel Forearm blockDrug
Also called bupivacaine liposome injectable suspension
20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
Bupivacaine supraclavicular blockDrug
20-30mL 0.5% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Exparel forearm block | Experimental | Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. Receives: Drug: Exparel Forearm block |
| Bupivacaine supraclavicular block | Active comparator | Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. Receives: Drug: Bupivacaine supraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Sensorimotor Block
A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: PI leaving instutition
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 Hand InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Soberon, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- 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
- NCT02058303
- Sponsor's protocol ID
- 04262013
- Status last verified
- May 2024
- First submitted
- 6 Feb 2014
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02058303
- Acronym / sponsor ID
- 04262013
- Conditions
- Hand Injuries, Wrist Injuries, Finger Injuries
- Keywords
- hand surgery, wrist surgery, finger surgery, anesthesia, regional anesthesia, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving instutition
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Jose Soberon, MDUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Feb 2014 (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 compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel forearm block | Experimental | Drug: Exparel Forearm blockUnder ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. |
| Bupivacaine supraclavicular block | Active comparator | Drug: Bupivacaine supraclavicular blockUnder ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients 18 years or older having hand, wrist, or finger surgery
- ability to understand and provide informed consent
- American Society of Anesthesiologists status I-III
- presence of a responsible adult caregiver for 48-72 hours after surgery
Key exclusion criteria (10 listed)
- patient refusal or inability to provide informed consent
- true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol
- pregnancy
- hepatic or renal failure
- 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 |
|---|---|---|
| Exparel Forearm blockAlso: bupivacaine liposome injectable suspension20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. | Drug | Exparel forearm block |
| Bupivacaine supraclavicular block20-30mL 0.5% bupivacaine | Drug | Bupivacaine supraclavicular block |
Primary outcome
Onset of Sensorimotor Block
Time frame: 30 minutes
A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.
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.
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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 4 study testing Exparel Forearm block and Bupivacaine supraclavicular block in people with Hand Injuries and Wrist Injuries, 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 4 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: 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 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?
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?
Onset of Sensorimotor Block (time frame: 30 minutes). 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.