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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please email ngvivienne@cd-tr.wales.nhs.uk to request a patient information sheet
Scientific titleComparison of dose and concentration of local anaesthetics in femoral sciatic block: a randomised controlled trial
Study objectivesNull 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) studiedAnalgesic in regional anaesthesia
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Levobupivacaine, lidocaine
Primary outcome measureAnalgesia usage within the first 24 hours.
Secondary outcome measures1. Side effects
2. Motor blockade
Overall study start date01/05/2009
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit100 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. Children <18 years old
2. Pregnant women
3. Patients with contraindications to spinal anaesthetic
4. Patients unable to give informed consent
Date of first enrolment01/05/2009
Date of final enrolment30/04/2010

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

14/06/2016: No publications found, verifying study status with principal investigator.