Postoperative MobilityPhase 4NCT01927289
DBRCT on the Effect of Grip Strength in Brachial Plexus vs Distal Forearm Nerve Blocks
A Phase 4 study testing Proximal Brachial Plexus vs Distal Forearm Block in people with Postoperative Mobility, run by University of New Mexico at 1 site in United States.
Trial summary
This is a double-blind prospective randomized control trial. The primary hypothesis is that the preservation of motor function is superior in distal forearm blocks compared to supraclavicular block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Mobility
- What is being tested?
- Proximal Brachial Plexus vs Distal Forearm Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Aug 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I to III
- Aged 18 and above
- Able to provide own consent
- Elective ambulatory surgery in the hand with an expected surgical time of less than 15 minutes that is normally performed with a peripheral nerve block covering the median and ulnar nerve distributions and intravenous sedation without general anesthesia
Who cannot join
- 1) Surgery outside the median and ulnar nerve distribution in the hand 2) Bilateral surgery 3) body mass index of more than 45 kg/m2 (higher chance of failure) 4) neck or clavicle deformities 5) infection at the injection site 6) existing neurologic disease 7) insulin dependent diabetes 8) Diabetes with peripheral neuropathy or end organ damage 9) allergy to LA agents 10) coagulopathy 11) Past surgery on the same upper limb 12) Any other contraindication to supraclavicular block or forearm blocks 13) Contraindication to monitored anesthesia care with peripheral nerve block as the mode of anesthesia.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: A Double-blind Randomized Controlled Trial Between Ultrasound-guided Brachial Plexus and Distal Peripheral Nerve Blocks for Hand Surgery
This is a double-blind prospective randomized control trial. The primary hypothesis is that the preservation of motor function is superior in distal forearm blocks compared to supraclavicular block. The secondary outcomes include patient satisfaction, surgeon's satisfaction, rate of block success, onset and duration of block.
- Conditions
- Postoperative Mobility
- Being tested
- Proximal Brachial Plexus vs Distal Forearm Block
- Keywords
- Ultrasound, supraclavicular block, distal forearm block, Grip Strength, Satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Brachial Plexus vs Distal Forearm BlockProcedure or surgery
Also called Supracalvicular block, Wrist block
Proximal Brachial plexus block: 15 mls saline injected in distal forearm nerve block and 15 mls of 1.5% Mepivacaine injected to the brachial plexus via the supraclavicular approach.
Distal forearm block: 15 mls 1.5% Mepivacaine injected in distal forearm nerve block and 15 mls of saline injected to the brachial plexus via the supraclavicular approach
| Study group | Role | What they receive |
|---|---|---|
| Proximal Brachial Plexus block | Active comparator | 15 mls of 1.5% Mepivacaine injected in the supraclavicular approach and 15 mls of saline injected in the distal forarm nerve blocks Receives: Procedure: Proximal Brachial Plexus vs Distal Forearm Block |
| Distal Forearm block | Active comparator | 15 mls 1.5% Mepivacaine injected in distal forearm nerve block and 15 mls of saline injected to the brachial plexus via the supraclavicular approach Receives: Procedure: Proximal Brachial Plexus vs Distal Forearm Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Maximal Grip Strength x3 using dynanometer
Measured: 6 months
Secondary outcomes (1)
Patient Satisfaction
Patient satisfaction on a linear numerical scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative MobilityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Nicholas Lam, University of New Mexico
- Investigators
- Nicholas Lam, MD, Principal investigator, UNM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927289
- Sponsor's protocol ID
- Lamproxvsdistal
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Trial Between Ultrasound-guided Brachial Plexus and Distal Peripheral Nerve Blocks for Hand Surgery
- ClinicalTrials.gov ID
- NCT01927289
- Acronym / sponsor ID
- Lamproxvsdistal
- Conditions
- Postoperative Mobility
- Keywords
- Ultrasound, supraclavicular block, distal forearm block, Grip Strength, Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Aug 2013 (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.
This is a double-blind prospective randomized control trial. The primary hypothesis is that the preservation of motor function is superior in distal forearm blocks compared to supraclavicular block. The secondary outcomes include patient satisfaction, surgeon's satisfaction, rate of block success, onset and duration of block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal Brachial Plexus block | Active comparator | Procedure: Proximal Brachial Plexus vs Distal Forearm Block15 mls of 1.5% Mepivacaine injected in the supraclavicular approach and 15 mls of saline injected in the distal forarm nerve blocks |
| Distal Forearm block | Active comparator | Procedure: Proximal Brachial Plexus vs Distal Forearm Block15 mls 1.5% Mepivacaine injected in distal forearm nerve block and 15 mls of saline injected to the brachial plexus via the supraclavicular approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists physical status I to III
- Aged 18 and above
- Able to provide own consent
- Elective ambulatory surgery in the hand with an expected surgical time of less than 15 minutes that is normally performed with a peripheral nerve block covering the median and ulnar nerve distributions and intravenous sedation without general anesthesia
Key exclusion criteria (2 listed)
- 1) Surgery outside the median and ulnar nerve distribution in the hand 2) Bilateral surgery 3) body mass index of more than 45 kg/m2 (higher chance of failure) 4) neck or clavicle deformities 5) infection at the injection site 6) existing neurologic disease 7) insulin dependent diabetes 8) Diabetes with peripheral neuropathy or end organ damage 9) allergy to LA agents 10) coagulopathy 11) Past surgery on the same upper limb 12) Any other contraindication to supraclavicular block or forearm blocks 13) Contraindication to monitored anesthesia care with peripheral nerve block as the mode of anesthesia.
- -
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 |
|---|---|---|
| Proximal Brachial Plexus vs Distal Forearm BlockAlso: Supracalvicular block, Wrist blockProximal Brachial plexus block: 15 mls saline injected in distal forearm nerve block and 15 mls of 1.5% Mepivacaine injected to the brachial plexus via the supraclavicular approach. Distal forearm block: 15 mls 1.5% Mepivacaine injected in distal forearm nerve block and 15 mls of saline injected to the brachial plexus via the supraclavicular approach | Procedure or surgery | Distal Forearm block, Proximal Brachial Plexus block |
Primary outcome
Grip Strength
Time frame: 6 months
Maximal Grip Strength x3 using dynanometer
1 secondary outcome
Patient Satisfaction
Time frame: 6 months
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 Aug 2013.
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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.
Nicholas Lam, MD principal investigator
UNM
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 Proximal Brachial Plexus vs Distal Forearm Block in people with Postoperative Mobility, run by University of New Mexico 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 2 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 Aug 2013. 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?
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?
Grip Strength (time frame: 6 months). 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 Aug 2013.