Contact information
Type
Scientific
Primary contact
Dr Mohammed Alhelail
ORCID ID
Contact details
P.O. Box 230691
Riyadh
11321
Saudi Arabia
+966 (0) 1 505 225 402
alhelail@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2061015
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
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.
Study design
Single-centre randomised, double-blinded, prospective study with a single self-controlled arm
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Injection pain in digital nerve blocks
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Bupivacaine, lidocaine, epinephrine
Primary outcome measure
The primary outcome was the pain of injection, and it was measured using a 0- to 100-mm visual analog scale (VAS).
Secondary outcome measures
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
Overall trial start date
27/08/2006
Overall trial end date
28/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
12
Participant exclusion criteria
Does not meet above inclusion criteria.
Recruitment start date
27/08/2006
Recruitment end date
28/08/2006
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
P.O. Box 230691
Riyadh
11321
Saudi Arabia
Sponsor information
Organisation
King Faisal Specialist Hospital and Research Center (Saudi Arabia)
Sponsor details
P.O. Box 3354
Riyadh
11211
Saudi Arabia
weam@kfshrc.edu.sa
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
King Faisal Specialist Hospital and Research Centre (Saudi Arabia)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Saudi Arabia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19386869
Publication citations
-
Results
Alhelail M, Al-Salamah M, Al-Mulhim M, Al-Hamid S, Comparison of bupivacaine and lidocaine with epinephrine for digital nerve blocks., Emerg Med J, 2009, 26, 5, 347-350, doi: 10.1136/emj.2008.062497.