Contact information
Type
Scientific
Primary contact
Dr Vivienne Ng
ORCID ID
Contact details
Anaesthetics Department
Glan Clwyd Hospital
Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom
+44 (0)1745 583910
hyvng@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of dose and concentration of local anaesthetics in femoral sciatic block: a randomised controlled trial
Acronym
Study hypothesis
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
To be submitted to the North Wales (Central) Research Ethics Committee in March 2009 (ref: 09/WNo02/7) as of 02/03/2009.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please email ngvivienne@cd-tr.wales.nhs.uk to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Levobupivacaine, lidocaine
Primary outcome measures
Analgesia usage within the first 24 hours.
Secondary outcome measures
1. Side effects
2. Motor blockade
Overall trial start date
01/05/2009
Overall trial end date
30/04/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Children <18 years old
2. Pregnant women
3. Patients with contraindications to spinal anaesthetic
4. Patients unable to give informed consent
Recruitment start date
01/05/2009
Recruitment end date
30/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics Department
Denbighshire
LL18 5UJ
United Kingdom
Sponsor information
Organisation
North Wales NHS Trust (UK)
Sponsor details
Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom
+44 (0)1745 583910
Lona.tudorjones@cd-tr.wales.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Wales NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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