Hand or Arm SurgeryNCT00992810
Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular Block
A study testing Lateral-to-Medial Approach and Media-to-Lateral Approach in people with Hand or Arm Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The ultrasound guided supraclavicular block is a peripheral nerve block which is considered safe, has a fast onset, is dense and provides complete block of the nerves supplying the hand, forearm and arm. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hand or Arm Surgery
- What is being tested?
- Lateral-to-Medial Approach and Media-to-Lateral Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Sep 2010
- 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
- Adult patients presenting for upper limb surgery, excluding shoulder surgery
- Age 18-80 yrs
- BMI < 35
- ASA I - III
- Consent for the study
Who cannot join
- Pre-existing sensory or motor neurodeficit.
- Sensitivity to local anaesthetic agents.
- Patients on anticoagulants or antiplatelet medications (Minidose Aspirin is acceptable) with abnormal coagulation profile.
- Compromised pulmonary reserve due to COPD, Kypho-scoliosis or Restricted lung disease.
- Infection or any obvious pathology at the site of block performance
- History of drug abuse.
- Psychiatric disease or any condition that precludes an informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medial vs. Lateral Approach to Ultrasound-Guided Supraclavicular Block: A Prospective Randomized Controlled Trial
The ultrasound guided supraclavicular block is a peripheral nerve block which is considered safe, has a fast onset, is dense and provides complete block of the nerves supplying the hand, forearm and arm. However retrospective studies done at Toronto Western Hospital have highlighted the fact that most commonly the ulnar nerve fibres (responsible for sensations in the ring finger, little finger and the corresponding part of hand), sometimes escape this block and need additional supplementary block at a distal peripheral nerve site. It is a confusing fact since all nerve fibres are compactly arranged in a sheath at the supraclavicular level. The local anaesthetic agent at this level should be equally distributed among all nerve fibres. The purpose of this study is to compare two different approaches (medial and lateral) adopted by our clinicians to perform this block and to test the effectiveness of each approach for successful ulnar nerve fibre blockade.
- Conditions
- Hand or Arm Surgery
- Being tested
- Lateral-to-Medial Approach, Media-to-Lateral Approach
- Keywords
- upper limb, hand, arm, surgery, supraclavicular nerve block, brachial plexus nerve block, ultrasound-guided regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral-to-Medial ApproachProcedure or surgery
Approach of the needle to administer the brachial plexus nerve block will be done in a lateral-to-medial direction.
Media-to-Lateral ApproachProcedure or surgery
Approach of the needle to administer the brachial plexus nerve block will be done in a medial-to-lateral direction.
| Study group | Role | What they receive |
|---|---|---|
| Lateral-to-Medial Approach | Experimental | Needle approach to the brachial plexus nerves will be made using a lateral-to-medial direction. Receives: Procedure: Lateral-to-Medial Approach |
| Medial-to-Lateral Approach | Experimental | Needle approach to the brachial plexus nerves will be made using a lateral-to-medial direction. Receives: Procedure: Media-to-Lateral Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful block of the Ulnar nerve (C8,T1) fibres. Sensory block with a score of '1' at 30 minutes (loss of sensation to pin prick) is considered successful.
Measured: 1 hour prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand or Arm SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992810
- Sponsor's protocol ID
- 09-0451-B
- Status last verified
- Jan 2010
- First submitted
- 8 Oct 2009
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial vs. Lateral Approach to Ultrasound-Guided Supraclavicular Block: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00992810
- Acronym / sponsor ID
- 09-0451-B
- Conditions
- Hand or Arm Surgery
- Keywords
- upper limb, hand, arm, surgery, supraclavicular nerve block, brachial plexus nerve block, ultrasound-guided regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Oct 2009 (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 ultrasound guided supraclavicular block is a peripheral nerve block which is considered safe, has a fast onset, is dense and provides complete block of the nerves supplying the hand, forearm and arm. However retrospective studies done at Toronto Western Hospital have highlighted the fact that most commonly the ulnar nerve fibres (responsible for sensations in the ring finger, little finger and the corresponding part of hand), sometimes escape this block and need additional supplementary block at a distal peripheral nerve site. It is a confusing fact since all nerve fibres are compactly arranged in a sheath at the supraclavicular level. The local anaesthetic agent at this level should be equally distributed among all nerve fibres. The purpose of this study is to compare two different approaches (medial and lateral) adopted by our clinicians to perform this block and to test the effectiveness of each approach for successful ulnar nerve fibre blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral-to-Medial Approach | Experimental | Procedure: Lateral-to-Medial ApproachNeedle approach to the brachial plexus nerves will be made using a lateral-to-medial direction. |
| Medial-to-Lateral Approach | Experimental | Procedure: Media-to-Lateral ApproachNeedle approach to the brachial plexus nerves will be made using a lateral-to-medial direction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients presenting for upper limb surgery, excluding shoulder surgery
- Age 18-80 yrs
- BMI < 35
- ASA I - III
- Consent for the study
Key exclusion criteria (7 listed)
- Pre-existing sensory or motor neurodeficit.
- Sensitivity to local anaesthetic agents.
- Patients on anticoagulants or antiplatelet medications (Minidose Aspirin is acceptable) with abnormal coagulation profile.
- Compromised pulmonary reserve due to COPD, Kypho-scoliosis or Restricted lung disease.
- Infection or any obvious pathology at the site of block performance
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 |
|---|---|---|
| Lateral-to-Medial ApproachApproach of the needle to administer the brachial plexus nerve block will be done in a lateral-to-medial direction. | Procedure or surgery | Lateral-to-Medial Approach |
| Media-to-Lateral ApproachApproach of the needle to administer the brachial plexus nerve block will be done in a medial-to-lateral direction. | Procedure or surgery | Medial-to-Lateral Approach |
Primary outcome
Successful block of the Ulnar nerve (C8,T1) fibres. Sensory block with a score of '1' at 30 minutes (loss of sensation to pin prick) is considered successful.
Time frame: 1 hour prior to 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 4 Dec 2017.
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.
Richard Brull, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral-to-Medial Approach and Media-to-Lateral Approach in people with Hand or Arm Surgery, run by University Health Network, Toronto 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 5 inclusion and 7 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 4 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?
Successful block of the Ulnar nerve (C8,T1) fibres. Sensory block with a score of '1' at 30 minutes (loss of sensation to pin prick) is considered successful. (time frame: 1 hour prior to surgery). 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 4 Dec 2017.