Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular Block
Recruitment status was Recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 8, 2009 | ||||
| Last Updated Date | January 22, 2010 | ||||
| Start Date ICMJE | August 2009 | ||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00992810 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular Block | ||||
| Official Title ICMJE | Medial vs. Lateral Approach to Ultrasound-Guided Supraclavicular Block: A Prospective Randomized Controlled Trial | ||||
| Brief 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. 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Hand or Arm Surgery | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 78 | ||||
| Estimated Completion Date | September 2010 | ||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00992810 | ||||
| Other Study ID Numbers ICMJE | 09-0451-B | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Richard Brull, University Health Network | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | January 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||