Disorder of Upper ExtremityNCT01136447
Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound
A study testing Ultrasound in people with Disorder of Upper Extremity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether ultrasound guidance or nerve stimulation is the best option for placing continuous peripheral nerve block catheters for upper limb surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder of Upper Extremity
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Feb 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 yrs
- Weight 40-100 kg
- Either sex
- Height >150 cm
- American Society of Anesthesiologists physical status 1-3
- Scheduled for hand or elbow surgery under regional anesthesia
Who cannot join
- Inability to give informed consent
- Refusal of treatment randomization
- Language barrier
- Allergy to any medications being used in the study protocol
- Ongoing major medical or psychiatric problems
- Chronic pain or narcotic use/abuse
Show all 14Show fewer
- Peripheral neuropathy or major neurological problems
- Scarring in area of blockade
- Inability to co-operate with post-operative evaluation
- Major coagulopathy
- Pregnancy and breast feeding
- Patients requiring anesthesia of other surgical sites
- Obese patients (i.e. BMI >40)
- Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual protocol of care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Success Rate of Infra-clavicular Blocks: Comparison of Ultrasound Versus Neurostimulation Guided Catheter Placement
The purpose of this study is to determine whether ultrasound guidance or nerve stimulation is the best option for placing continuous peripheral nerve block catheters for upper limb surgery.
Read the detailed description
In a multidisciplinary, observer blinded, prospective, single center, randomized study, success rate of US guided versus neurostimulation guided catheter placement for continuous infraclavicular block in patients scheduled for upper limb surgery will be studied. Block effectiveness, time taken, discharge from recovery, postoperative pain and disability and patient acceptance will be studied in 210 patients.
- Conditions
- Disorder of Upper Extremity
- Being tested
- Ultrasound
- Keywords
- Brachial plexus, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Block catheter will be introduced using ultraosound
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulation | Placebo comparator | Block catheter will be introduced using neurostimulation Receives: Procedure: Ultrasound |
| Ultrasound | Active comparator | Block catheter will be introduced using ultrasound Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurostimulation versus ultrasound guided infraclavicular catheter placement
Comparision of block success with neurostimulation and ultrasound guided placed infraclavicular catheters
Measured: 14 days
Secondary outcomes (1)
Time taken for complete nerve block
Procedure time for both techniques
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Upper ExtremityStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Shalini Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shalini Dhir, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136447
- Sponsor's protocol ID
- R-06-101
- Other IDs
- 12208
- Status last verified
- Aug 2017
- First submitted
- 20 Apr 2009
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate of Infra-clavicular Blocks: Comparison of Ultrasound Versus Neurostimulation Guided Catheter Placement
- ClinicalTrials.gov ID
- NCT01136447
- Acronym / sponsor ID
- R-06-101
- Conditions
- Disorder of Upper Extremity
- Keywords
- Brachial plexus, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Jun 2010 (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 determine whether ultrasound guidance or nerve stimulation is the best option for placing continuous peripheral nerve block catheters for upper limb surgery.
Detailed description
In a multidisciplinary, observer blinded, prospective, single center, randomized study, success rate of US guided versus neurostimulation guided catheter placement for continuous infraclavicular block in patients scheduled for upper limb surgery will be studied. Block effectiveness, time taken, discharge from recovery, postoperative pain and disability and patient acceptance will be studied in 210 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurostimulation | Placebo comparator | Procedure: UltrasoundBlock catheter will be introduced using neurostimulation |
| Ultrasound | Active comparator | Procedure: UltrasoundBlock catheter will be introduced using ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 yrs
- Weight 40-100 kg
- Either sex
- Height >150 cm
- American Society of Anesthesiologists physical status 1-3
Key exclusion criteria (14 listed)
- Inability to give informed consent
- Refusal of treatment randomization
- Language barrier
- Allergy to any medications being used in the study protocol
- Ongoing major medical or psychiatric problems
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 |
|---|---|---|
| UltrasoundBlock catheter will be introduced using ultraosound | Procedure or surgery | Neurostimulation, Ultrasound |
Primary outcome
Neurostimulation versus ultrasound guided infraclavicular catheter placement
Time frame: 14 days
Comparision of block success with neurostimulation and ultrasound guided placed infraclavicular catheters
1 secondary outcome
Time taken for complete nerve block
Time frame: 14 days
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 30 Aug 2017.
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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.
Shalini Dhir, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Disorder of Upper Extremity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 6 inclusion and 14 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 30 Aug 2017. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Neurostimulation versus ultrasound guided infraclavicular catheter placement (time frame: 14 days). 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 30 Aug 2017.