Hand InjuryNCT02112006
Comparing Two Injection Sites of Local Anesthetic for Hand Surgery
A study testing 0.5% bupivacaine injected in the forearm and 20-30ml of 0.5% bupivacaine. in people with Hand Injury and Wrist Injury, run by Jose Soberon, MD at 1 site in United States.
Trial summary
The purpose of this study is to compare two different injection sites for local anesthesia in patients having hand surgery. The hypothesis is that subjects receiving injections around the three nerves of the forearm will provide faster pain control and greater patient satisfaction than patients having one injection… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Injury, Wrist Injury, Finger Injury
- What is being tested?
- 0.5% bupivacaine injected in the forearm and 20-30ml of 0.5% bupivacaine.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Mar 2016
- Phase
- Interventional
- 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
- Patients ≥ 18 years of age undergoing unilateral hand, wrist, or finger surgery
- Ability to understand and provide informed consent
- American Society of Anesthesiologists (ASA) status I-III
Who cannot join
- Patient refusal or inability to provide informed consent
- True allergy, not sensitivity, to any of the following substances: Local Anesthetics, Midazolam, Fentanyl, Hydromorphone, Propofol
- 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 designee
- Pulmonary disease of any kind that is uncontrolled or severe in nature
- Chronic pain patients, defined as someone diagnosed with chronic pain or a chronic pain condition, under the care of a chronic pain physician, or taking oral/intravenous narcotics consistently for 30 days prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
About this study
Official title: A Comparison Of Distal Peripheral Nerve Blockade Versus Traditional Proximal Approaches For Hand Surgery
The purpose of this study is to compare two different injection sites for local anesthesia in patients having hand surgery. The hypothesis is that subjects receiving injections around the three nerves of the forearm will provide faster pain control and greater patient satisfaction than patients having one injection closer to the shoulder.
- Conditions
- Hand Injury, Wrist Injury, Finger Injury
- Being tested
- 0.5% bupivacaine injected in the forearm, 20-30ml of 0.5% bupivacaine.
- 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.
0.5% bupivacaine injected in the forearmProcedure or surgery
Median, Ulnar, and Radial nerve blocks performed in the forearm
20-30ml of 0.5% bupivacaine.Procedure or surgery
supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| distal injection | Experimental | 0.5% bupivacaine injected in the forearm Receives: Procedure: 0.5% bupivacaine injected in the forearm |
| proximal injection | Active comparator | 20-30ml of 0.5% bupivacaine Receives: Procedure: 20-30ml of 0.5% bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of block
number of participants that needed additional anesthesia
Measured: up to 30 minutes after injection
Secondary outcomes (1)
pain scores
change in pain scores
Measured: up to 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT02112006
- Sponsor's protocol ID
- Soberon Forearm
- Status last verified
- Oct 2015
- First submitted
- 8 Apr 2014
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of Distal Peripheral Nerve Blockade Versus Traditional Proximal Approaches For Hand Surgery
- ClinicalTrials.gov ID
- NCT02112006
- Acronym / sponsor ID
- Soberon Forearm
- Conditions
- Hand Injury, Wrist Injury, Finger Injury
- Keywords
- hand surgery, wrist surgery, finger surgery, anesthesia, regional anesthesia, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jose Soberon, MDUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Apr 2014 (estimated)
- 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 purpose of this study is to compare two different injection sites for local anesthesia in patients having hand surgery. The hypothesis is that subjects receiving injections around the three nerves of the forearm will provide faster pain control and greater patient satisfaction than patients having one injection closer to the shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| distal injection | Experimental | Procedure: 0.5% bupivacaine injected in the forearm0.5% bupivacaine injected in the forearm |
| proximal injection | Active comparator | Procedure: 20-30ml of 0.5% bupivacaine.20-30ml of 0.5% bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years of age undergoing unilateral hand, wrist, or finger surgery
- Ability to understand and provide informed consent
- American Society of Anesthesiologists (ASA) status I-III
Key exclusion criteria (8 listed)
- Patient refusal or inability to provide informed consent
- True allergy, not sensitivity, to any of the following substances: Local Anesthetics, Midazolam, Fentanyl, Hydromorphone, Propofol
- 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 |
|---|---|---|
| 0.5% bupivacaine injected in the forearmMedian, Ulnar, and Radial nerve blocks performed in the forearm | Procedure or surgery | distal injection |
| 20-30ml of 0.5% bupivacaine.supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine. | Procedure or surgery | proximal injection |
Primary outcome
success of block
Time frame: up to 30 minutes after injection
number of participants that needed additional anesthesia
1 secondary outcome
pain scores
Time frame: up to 10 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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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 study testing 0.5% bupivacaine injected in the forearm and 20-30ml of 0.5% bupivacaine. in people with Hand Injury and Wrist Injury, 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 22 Mar 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
success of block (time frame: up to 30 minutes after injection). 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 22 Mar 2016.