To compare dose and concentration of local anaesthetics in regional anaesthesia
ISRCTN | ISRCTN44947124 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN44947124 |
Secondary identifying numbers | N/A |
- Submission date
- 02/03/2009
- Registration date
- 27/03/2009
- Last edited
- 14/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Vivienne Ng
Scientific
Scientific
Anaesthetics Department
Glan Clwyd Hospital
Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom
Phone | +44 (0)1745 583910 |
---|---|
hyvng@doctors.org.uk |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please email ngvivienne@cd-tr.wales.nhs.uk to request a patient information sheet |
Scientific title | Comparison of dose and concentration of local anaesthetics in femoral sciatic block: a randomised controlled trial |
Study objectives | Null hypothesis: There is no difference in volume and concentration of local anaesthetics used in the sciatic component of a femoral sciatic block as long as the total dose is constant. |
Ethics approval(s) | To be submitted to the North Wales (Central) Research Ethics Committee in March 2009 (ref: 09/WNo02/7) as of 02/03/2009. |
Health condition(s) or problem(s) studied | Analgesic in regional anaesthesia |
Intervention | The 40 patients will be randomised into 2 groups: The first group will be given 20 ml of levobupivacaine 02.5% with 20 ml of lidocaine 1% for each block. The second group will be given 20 ml of levobupivacaine 02.5% with 20 ml of lidocaine 1% for the femoral block and 10 ml of levobupivacaine 0.5% with 10 ml of lidocaine 2% for the sciatic block. To minimise operator factors, there will be three anaesthetists performing the anaesthesia. Intraoperatively, patients will be given 1 g paracetamol (intravenous). Patients are observed postoperatively in high care and the usage of PCA morphine as well as side effects will be monitored closely. Patients are only given paracetamol 1 g four times a day (qds) in the first 24 hours as well as the morphine PCA. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Levobupivacaine, lidocaine |
Primary outcome measure | Analgesia usage within the first 24 hours. |
Secondary outcome measures | 1. Side effects 2. Motor blockade |
Overall study start date | 01/05/2009 |
Completion date | 30/04/2010 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 100 Years |
Sex | Both |
Target number of participants | 40 |
Key inclusion criteria | 1. Both males and females, aged 18-100 2. American Society of Anesthesiologists (ASA) 1 and 2 3. Patients undergoing femoral sciatic blocks for elective orthopaedic surgery |
Key exclusion criteria | 1. Children <18 years old 2. Pregnant women 3. Patients with contraindications to spinal anaesthetic 4. Patients unable to give informed consent |
Date of first enrolment | 01/05/2009 |
Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Anaesthetics Department
Denbighshire
LL18 5UJ
United Kingdom
LL18 5UJ
United Kingdom
Sponsor information
North Wales NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Bodelwyddan
Denbighshire
LL18 5UJ
Wales
United Kingdom
Phone | +44 (0)1745 583910 |
---|---|
Lona.tudorjones@cd-tr.wales.nhs.uk | |
Website | http://www.wales.nhs.uk/sites3/home.cfm?orgid=802 |
https://ror.org/04a496k07 |
Funders
Funder type
Government
North Wales NHS Trust (UK)
No information available
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 |
Editorial Notes
14/06/2016: No publications found, verifying study status with principal investigator.