Comparison of bupivacaine and lidocaine with epinephrine for digital nerve blocks
| ISRCTN | ISRCTN45121950 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45121950 |
| Protocol serial number | 2061015 |
| Sponsor | King Faisal Specialist Hospital and Research Center (Saudi Arabia) |
| Funder | King Faisal Specialist Hospital and Research Centre (Saudi Arabia) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Mohammed Alhelail
Scientific
Scientific
P.O. Box 230691
Riyadh
11321
Saudi Arabia
| Phone | +966 (0) 1 505 225 402 |
|---|---|
| alhelail@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised, double-blinded, prospective study with a single self-controlled arm |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Bupivacaine, lidocaine, epinephrine |
| Primary outcome measure(s) |
The primary outcome was the pain of injection, and it was measured using a 0- to 100-mm visual analog scale (VAS). |
| Key secondary outcome measure(s) |
1. The time in minutes from injection until anaesthesia, measured using testing needle pinpricks |
| Completion date | 28/08/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Key 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 |
| Key exclusion criteria | Does not meet above inclusion criteria. |
| Date of first enrolment | 27/08/2006 |
| Date of final enrolment | 28/08/2006 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
P.O. Box 230691
Riyadh
11321
Saudi Arabia
11321
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
