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ISRCTN
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ISRCTN45121950
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ClinicalTrials.gov identifier
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Public title
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Comparison of bupivacaine and lidocaine with epinephrine for digital nerve blocks
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Scientific title
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Acronym
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N/A
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Serial number at source
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2061015
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Study hypothesis
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In this study, we are comparing bupivacaine versus lidocaine with epinephrine when used for the digital block in healthy volunteers aiming to know if there is a difference in the pain of injection. Time of onset and duration of action will also be recorded and compared between the two local anaesthetics.
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Ethics approval
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Ethics approval received from:
1. The Clinical Research Committee of King Faisal Specialist Hospital and Research Center, Riyadh (Saudi Arabia) on the 17th May 2006 (proposal no.: 2061015)
2. The Research Ethics Committee of King Faisal Specialist Hospital and Research Center, Riyadh (Saudi Arabia) on the 12th June 2006
The reference number at the Office of Research Affair at King Faisal Specialist Hospital and Research Center, Riyadh (Saudi Arabia) is ORA/0642/27.
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Study design
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A single-centre randomised, double-blinded, prospective study with a single self-controlled arm
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Countries of recruitment
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Saudi Arabia
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Disease/condition/study domain
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Injection pain in digital nerve blocks
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Participants - inclusion criteria
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1. Healthy volunteers more than 18 years of age, either sex
2. No history of cardiovascular or liver disease
3. Not diabetic
4. No history of peripheral vascular disease
5. Not on any current medication
6. Has not taken analgesia within last 48 hours
7. Hasn't had any previous procedures conducted on both hands
8. No previous hand illness (e.g., Raynaud's disease)
9. No known allergies
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Participants - exclusion criteria
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Does not meet the above inclusion criteria.
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Anticipated start date
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27/08/2006
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Anticipated end date
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28/08/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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12
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Interventions
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1. Bupivacaine 0.5% (4 ml for each digit)
2. Lidocaine 1% with 1:100,000 epinephrin (4 ml for each digit)
Both anaesthetics were adminstered in either the right or left middle finger based on the randomisation table and each participant recieved both anaesthetics in either hand so each participant acts as a self-control to compare the pain of injection. All participants were blinded to which anaesthetics were going in each hand.
The total duration will be until the return of sensation and this will be followed by a 24-hour follow-up.
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Primary outcome measure(s)
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The primary outcome was the pain of injection, and it was measured using a 0- to 100-mm visual analog scale (VAS).
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Secondary outcome measure(s)
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1. The time in minutes from injection until anaesthesia, measured using testing needle pinpricks
2. The time in minutes from injection until return of sensation, measured using testing needle pinpricks
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Sources of funding
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King Faisal Specialist Hospital and Research Center (Saudi Arabia)
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Trial website
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Publications
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Contact name
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Dr
Mohammed
Alhelail
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Address
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P.O. Box 230691
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City/town
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Riyadh
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Zip/Postcode
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11321
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Country
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Saudi Arabia
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Tel
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+966 (0) 1 505 225 402
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Email
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alhelail@yahoo.com
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Sponsor
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King Faisal Specialist Hospital and Research Center (Saudi Arabia)
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Address
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P.O. Box 3354
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City/town
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Riyadh
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Zip/Postcode
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11211
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Country
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Saudi Arabia
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Email
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weam@kfshrc.edu.sa
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Sponsor website:
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http://bportal.kfshrc.edu.sa/wps/portal/bportal
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Date applied
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31/03/2008
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Last edited
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08/04/2008
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Date ISRCTN assigned
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08/04/2008
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