Condition category
Signs and Symptoms
Date applied
31/03/2008
Date assigned
08/04/2008
Last edited
11/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://bportal.kfshrc.edu.sa/wps/portal/bportal

Funders

Funder type

Hospital/treatment centre

Funder name

King Faisal Specialist Hospital and Research Centre (Saudi Arabia)

Alternative name(s)

King Faisal Specialist Hospital

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19386869

Publication citations

  1. 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.

Additional files

Editorial Notes