Other Biomechanical Lesions of Upper ExtremityNCT03112642
Nerve Stimulator for Patients With Upper Extremity Disease, Vascular or Orthopedic Surgery
A study testing Local anesthetic block [0.35% marcaine] and Braun DIG-R-C Stimuplex Blockade Monitor System in people with Other Biomechanical Lesions of Upper Extremity, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
To help determine if there is improved pain relief when a device that makes an arm muscle move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent feeling of pain (anesthesia) of the upper arm. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Other Biomechanical Lesions of Upper Extremity
- What is being tested?
- Local anesthetic block [0.35% marcaine] and Braun DIG-R-C Stimuplex Blockade Monitor System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 9 Mar 2021
- Phase
- Interventional
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and females 21 through 89
- Agree to study participation and signed the informed consent
- Scheduled for upper extremity surgery with ultrasound guided supraclavicular block -
Who cannot join
- Children
- Pregnant Women
- Persons with allergies to local anesthetics
- Persons with infections at or near site of needle insertion
- Patients with severe disturbance of cardiac rhythm and heart block
- Patients with severe respiratory compromise
Show all 11Show fewer
- Patients requiring bilateral upper extremity anesthesia
- Patients with coagulopathy or medical anticoagulation
- Patients with traumatic nerve injury to neck or upper extremity
- Patients with preexisting neurological deficits in the distribution of the block
- Patients with previous surgery to the neck that may distort brachial plexus anatomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
About this study
Official title: Does the Use of a Nerve Stimulator Improve the Outcome of Ultrasound-Guided Supraclavicular Block (Anesthesia) for Upper Extremity Surgery?
To help determine if there is improved pain relief when a device that makes an arm muscle move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent feeling of pain (anesthesia) of the upper arm.
Read the detailed description
The Investigators will use the assessment of onset of motor and sensory block Q 5 minutes to distinguish the difference between blocks performed with ultrasound guidance with or without a nerve blockade monitor.
- Being tested
- Local anesthetic block [0.35% marcaine], Braun DIG-R-C Stimuplex Blockade Monitor System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic block [0.35% marcaine]Procedure or surgery
Also called 40 ml of local anesthetic block [0.35% marcaine]
In the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block [0.35% marcaine] will be administered.
Braun DIG-R-C Stimuplex Blockade Monitor SystemDevice
The blockade system will be initially set at 1 milliamp. As the proximity of the tip of the needle to the components of the brachial plexus becomes evident by ultrasound approximation and the stimulation pattern of the hand and wrist, the output of the system will be reduced to .3-.5 milliamps. With use of the Braun DIG-R-C Stimuplex Blockade Monitor System.
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | Active comparator | In the Standard Group, in the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block [0.35% marcaine] will be administered into the brachial plexus of the upper limb being operated on, at the supraclavicular level. Receives: Procedure: Local anesthetic block [0.35% marcaine] |
| Test Group | Experimental | In this group, the ultrasound guided local anesthetic block into the brachial plexus at the supraclavicular level of the upper limb being operated on will be supplemented by use of a blockade monitor (Nerve stimulator device) to direct final placement of the needle for the nerve block.
Only this group of the patients will receive this intervention with sufficient detail so that it can be distinguished from the Test Group Receives: Procedure: Local anesthetic block [0.35% marcaine]; Device: Braun DIG-R-C Stimuplex Blockade Monitor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatomes With Complete Motor Block of the Upper Extremities at 30 Minutes
dermatomes (with full motor block) will be the outcome measure The investigators will be assessing changes between muscle strength in the myotomal distribution of the upper limb corresponding to the dermatome region of the brachial plexus following supraclavicular block, using the MRC power scale (medical research council scale, 0-5), with strength values obtained at time zero (initiation of the block), and to compared to subsequent measurements in 5 minute intervals until the final measurement at 30 minutes following the block.
Measured: 30 minutes post block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startNov 2013
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Why it stopped: covid pandemic limited participation
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 Other Biomechanical Lesions of Upper ExtremityStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Grubb, M.D., Rutgers, The State University of New Jersey
- Investigators
- William Grubb, DDS, MD, Principal investigator, Robert Wood Johnson University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112642
- Sponsor's protocol ID
- 0220110040
- Status last verified
- Mar 2024
- First submitted
- 3 Sep 2014
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of a Nerve Stimulator Improve the Outcome of Ultrasound-Guided Supraclavicular Block (Anesthesia) for Upper Extremity Surgery?
- ClinicalTrials.gov ID
- NCT03112642
- Acronym / sponsor ID
- 0220110040
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: covid pandemic limited participation
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To help determine if there is improved pain relief when a device that makes an arm muscle move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent feeling of pain (anesthesia) of the upper arm.
Detailed description
The Investigators will use the assessment of onset of motor and sensory block Q 5 minutes to distinguish the difference between blocks performed with ultrasound guidance with or without a nerve blockade monitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Group | Active comparator | Procedure: Local anesthetic block [0.35% marcaine]In the Standard Group, in the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block [0.35% marcaine] will be administered into the brachial plexus of the upper limb being operated on, at the supraclavicular level. |
| Test Group | Experimental | Procedure: Local anesthetic block [0.35% marcaine], Device: Braun DIG-R-C Stimuplex Blockade Monitor SystemIn this group, the ultrasound guided local anesthetic block into the brachial plexus at the supraclavicular level of the upper limb being operated on will be supplemented by use of a blockade monitor (Nerve stimulator device) to direct final placement of the needle for the nerve block. Only this group of the patients will receive this intervention with sufficient detail so that it can be distinguished from the Test Group |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and females 21 through 89
- Agree to study participation and signed the informed consent
- Scheduled for upper extremity surgery with ultrasound guided supraclavicular block -
Key exclusion criteria (11 listed)
- Children
- Pregnant Women
- Persons with allergies to local anesthetics
- Persons with infections at or near site of needle insertion
- Patients with severe disturbance of cardiac rhythm and heart block
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 |
|---|---|---|
| Local anesthetic block [0.35% marcaine]Also: 40 ml of local anesthetic block [0.35% marcaine]In the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block [0.35% marcaine] will be administered. | Procedure or surgery | Standard Group, Test Group |
| Braun DIG-R-C Stimuplex Blockade Monitor SystemThe blockade system will be initially set at 1 milliamp. As the proximity of the tip of the needle to the components of the brachial plexus becomes evident by ultrasound approximation and the stimulation pattern of the hand and wrist, the output of the system will be reduced to .3-.5 milliamps. With use of the Braun DIG-R-C Stimuplex Blockade Monitor System. | Device | Test Group |
Primary outcome
Dermatomes With Complete Motor Block of the Upper Extremities at 30 Minutes
Time frame: 30 minutes post block
dermatomes (with full motor block) will be the outcome measure The investigators will be assessing changes between muscle strength in the myotomal distribution of the upper limb corresponding to the dermatome region of the brachial plexus following supraclavicular block, using the MRC power scale (medical research council scale, 0-5), with strength values obtained at time zero (initiation of the block), and to compared to subsequent measurements in 5 minute intervals until the final measurement at 30 minutes following the block.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
William Grubb, DDS, MD principal investigator
Robert Wood Johnson University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthetic block [0.35% marcaine] and Braun DIG-R-C Stimuplex Blockade Monitor System in people with Other Biomechanical Lesions of Upper Extremity, run by Rutgers, The State University of New Jersey 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 11 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 5 Mar 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 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?
Dermatomes With Complete Motor Block of the Upper Extremities at 30 Minutes (time frame: 30 minutes post block). 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 5 Mar 2024.