Condition category
Signs and Symptoms
Date applied
02/03/2009
Date assigned
27/03/2009
Last edited
14/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.wales.nhs.uk/sites3/home.cfm?orgid=802

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

Publication citations

Additional files

Editorial Notes

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