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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02714738 |
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Date of registration:
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16/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Infraclavicular Block: Decreased Incidence of Tourniquet Pain, Compared to Axillary Brachial Plexus Block?
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Scientific title:
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The Ultrasound Guided Infraclavicular Block: Decreased Incidence of Tourniquet Pain, Compared to Axillary Brachial Plexus Block? |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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82 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02714738 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Gabriella Iohom, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Consultant Anaesthetist, Senior Lecturer, Cork University Hospital / University College Cork |
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Name:
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George Shorten, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor of Anaesthesia and Intensive Care Medicine, Consultant Anaesthetist, University College Cork / Cork University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA I-III
- Orthopedic surgery at the level or distal to the elbow
- Expected tourniquet time > 45 min (K-wiring not suitable)
Exclusion Criteria:
- Contraindication of regional anaesthesia, patient is allergic to local anesthetics
- Clinically significant cognitive impairment (Minimental state score < 24)
- Chronic pain syndrome
- Preexisting nerve damage in the operated arm (sensory or motor deficit)
- Axillary clearance in the past
- History of peripheral neuropathy)
- Pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tourniquet Pain
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Intervention(s)
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Procedure: Ultrasound guided peripheral nerve block
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Primary Outcome(s)
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Incidence of tourniquet pain
[Time Frame: Intraoperative period]
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Secondary Outcome(s)
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Block performance time
[Time Frame: During block placement]
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Incidence of block failure
[Time Frame: 30 minutes after block placement]
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Incidence of adverse events
[Time Frame: During block placement]
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Block onset time
[Time Frame: 30 minutes after block placement]
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Onset time of tourniquet pain
[Time Frame: Intraoperative period]
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Severity of tourniquet pain
[Time Frame: Intraoperative period]
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Secondary ID(s)
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TP-ICB-ABPB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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