Cubital Tunnel SyndromeNCT02677506
Infraclavicular or Supraclavicular Brachial Plexus Blocks for Elbow Surgery
A study testing Supraclavicular and Infraclavicular in people with Cubital Tunnel Syndrome and Biceps Tendon Rupture, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study compares the infraclavicular approach to supraclavicular approach of brachial plexus block for elbow surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cubital Tunnel Syndrome, Biceps Tendon Rupture
- What is being tested?
- Supraclavicular and Infraclavicular
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for ambulatory elbow surgery under block
- ASA 1-3
Who cannot join
- Narcotic dependent
- Severe systemic illness
- Refusal of block
- localized infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Infraclavicular and Supraclavicular Brachial Plexus Blocks for Elbow Surgery
This study compares the infraclavicular approach to supraclavicular approach of brachial plexus block for elbow surgery.
Read the detailed description
Traditionally, infraclavicular as well as supraclavicular approaches to brachial plexus have been recommended for elbow surgery. Supraclavicular approach is considered to have a more rapid onset. However, investigators have noticed that the supraclavicular approach needs more supplementation if it is used for elbow surgery. Therefore more and more anesthesiologists now choose the infraclavicular approach for elbow surgery (though both approaches are recommended in the text books).
None of the published studies have addressed if one approach is indeed superior to the other specifically for elbow surgery. Therefore the investigators propose to undertake a study that will evaluate the two approaches to the brachial plexus specifically for elbow surgery.
- Conditions
- Cubital Tunnel Syndrome, Biceps Tendon Rupture
- Being tested
- Supraclavicular, Infraclavicular
- Keywords
- elbow
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupraclavicularProcedure or surgery
Brachial plexus block with supraclavicular approach
InfraclavicularProcedure or surgery
Brachial plexus block with infraclavicular approach
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular | Experimental | Supraclavicular brachial plexus block will be done. Receives: Procedure: Supraclavicular |
| Infraclavicular | Active comparator | Infraclavicular brachial plexus block block will be done. Receives: Procedure: Infraclavicular |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completion of block
A clock will be used to assess this outcome. Complete sensory block in all dermatomes will be tested with ice.
Measured: 30 minutes
Secondary outcomes (1)
Readiness for surgery
A clock will be used to assess this outcome. Complete sensory and motor block at the time of incision will be considered readiness of surgery.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 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
- Responsible party
- Principal investigator, Shalini Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shalini Dhir, FRCPC, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677506
- Sponsor's protocol ID
- 101723
- Status last verified
- Dec 2017
- First submitted
- 12 Jan 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Infraclavicular and Supraclavicular Brachial Plexus Blocks for Elbow Surgery
- ClinicalTrials.gov ID
- NCT02677506
- Acronym / sponsor ID
- 101723
- Conditions
- Cubital Tunnel Syndrome, Biceps Tendon Rupture
- Keywords
- elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Feb 2016 (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 study compares the infraclavicular approach to supraclavicular approach of brachial plexus block for elbow surgery.
Detailed description
Traditionally, infraclavicular as well as supraclavicular approaches to brachial plexus have been recommended for elbow surgery. Supraclavicular approach is considered to have a more rapid onset. However, investigators have noticed that the supraclavicular approach needs more supplementation if it is used for elbow surgery. Therefore more and more anesthesiologists now choose the infraclavicular approach for elbow surgery (though both approaches are recommended in the text books).
None of the published studies have addressed if one approach is indeed superior to the other specifically for elbow surgery. Therefore the investigators propose to undertake a study that will evaluate the two approaches to the brachial plexus specifically for elbow surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular | Experimental | Procedure: SupraclavicularSupraclavicular brachial plexus block will be done. |
| Infraclavicular | Active comparator | Procedure: InfraclavicularInfraclavicular brachial plexus block block will be done. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for ambulatory elbow surgery under block
- ASA 1-3
Key exclusion criteria (4 listed)
- Narcotic dependent
- Severe systemic illness
- Refusal of block
- localized infection
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 |
|---|---|---|
| SupraclavicularBrachial plexus block with supraclavicular approach | Procedure or surgery | Supraclavicular |
| InfraclavicularBrachial plexus block with infraclavicular approach | Procedure or surgery | Infraclavicular |
Primary outcome
Time to completion of block
Time frame: 30 minutes
A clock will be used to assess this outcome. Complete sensory block in all dermatomes will be tested with ice.
1 secondary outcome
Readiness for surgery
Time frame: 60 minutes
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 12 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Cubital Tunnel Syndrome
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome
Cubital Tunnel Syndrome
Recruiting
Comparison of Kinesio Taping Techniques in Ulnar Nerve Entrapment
Ulnar Nerve Entrapment, Cubital Tunnel Syndrome
Not yet recruitingObservational study
Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
Hand, Hand Therapy
Recruiting
Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome
Cubital Tunnel Syndrome, Electrical Stimulation
Recruiting
Investigation of the Effectiveness of Kinesiological Taping in Cubital Tunnel Syndrome
Cubital Tunnel Syndrome, Kinesio Taping
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, FRCPC principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraclavicular and Infraclavicular in people with Cubital Tunnel Syndrome and Biceps Tendon Rupture, 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 2 inclusion and 4 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 12 Dec 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. 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?
Time to completion of 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 12 Dec 2017.