Comparison of bupivacaine and lidocaine with epinephrine for digital nerve blocks

ISRCTN	ISRCTN45121950
DOI	https://doi.org/10.1186/ISRCTN45121950
Secondary identifying numbers	2061015

Submission date: 31/03/2008
Registration date: 08/04/2008
Last edited: 11/05/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Mohammed Alhelail
Scientific

P.O. Box 230691
Riyadh
11321
Saudi Arabia

Phone	+966 (0) 1 505 225 402
Email	alhelail@yahoo.com

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Scientific title
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(s)	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.
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	27/08/2006
Overall study end date	28/08/2006

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	12
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 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

Study participating centre

P.O. Box 230691

Riyadh
11321
Saudi Arabia

Sponsor information

King Faisal Specialist Hospital and Research Center (Saudi Arabia)
Hospital/treatment centre

P.O. Box 3354
Riyadh
11211
Saudi Arabia

Email	weam@kfshrc.edu.sa
Website	http://bportal.kfshrc.edu.sa/wps/portal/bportal
"ROR"	https://ror.org/05n0wgt02

Funders

Funder type

Hospital/treatment centre

King Faisal Specialist Hospital and Research Centre (Saudi Arabia)
Private sector organisation / Other non-profit organizations

Alternative name(s): King Faisal Specialist Hospital
Location: Saudi Arabia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No