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

Anaesthetics Department
Glan Clwyd Hospital
Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom

Phone	+44 (0)1745 583910
Email	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

Sponsor information

North Wales NHS Trust (UK)
Hospital/treatment centre

Bodelwyddan
Denbighshire
LL18 5UJ
Wales
United Kingdom

Phone	+44 (0)1745 583910
Email	Lona.tudorjones@cd-tr.wales.nhs.uk
Website	http://www.wales.nhs.uk/sites3/home.cfm?orgid=802
"ROR"	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.