Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000559
Study information
Scientific title
Comparison of fascia iliac compartment block with conventional sedation to facilitate the positioning of patients with fractured neck of femur for spinal anaesthesia and the effect of nerve blockade on post-operative pain and mobility: a randomised double-blind controlled study
Acronym
Study hypothesis
Part 1: Does the use of single shot fascia iliaca blockade reduce pain on patient positioning for spinal anaesthesia when compared with a standard sedation regime?
Part 2: Does the use of post-operative bolus dose fascia iliaca blockade improve pain and mobility outcomes in patients undergoing operative repair of fractured neck of femur?
Ethics approval
Health and Social Care Research Ethics Committee (HSC REC 1) (Northern Ireland), 18/04/2008, ref: 08/NIR01/20
Study design
Randomised controlled double-blind 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 use the contact details to request a patient information sheet
Condition
Operative repair of fractured neck of femur
Intervention
Part 1:
Patients randomised to receive either fascia iliaca compartment block (FICB) with 2 mg/kg 1% lignocaine or conventional sedation with 0.2 mg/kg intravenous (iv) ketamine and 0.025 mg/kg iv midazolam. At the end of surgery, a FICB using 1 mg/kg 0.25% levobupivacaine will be performed in all patients.
Part 2:
Patients randomised to receive a pre-operative FICB using either 1 mg/kg 0.25% levobupivacaine or 2 mg/kg 1% lignocaine. After administration of FICB a catheter will be inserted below the fascia iliaca and secured in place. Patients will be reviewed in the post-operative period and bolus doses of 0.125% levobupivacaine administered through the FICB catheter if Visual Analogue Scale (VAS) is greater than 4. The catheter will be removed no longer than 24 hours after surgery.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Part 1: Comparison of VAS score on rest and positioning for spinal anaesthesia in patients who have received either a fascia iliaca compartment block or convention sedation.
Part 2: Comparision between post-operative VAS scores in patients receiving fascia iliaca blockade with either lignocaine or levobupivacaine and the effect of bolus top-up doses of low dose levobupivacaine on VAS scores.
Secondary outcome measures
1. Length of time to first request of additional analgesia
2. The level of assistance required for transfer from the sitting to the standing position
3. Incidence and severity of motor blockade
4. Time taken to mobilisation with walking aid
5. Measurement of oxygen saturations without supplemental oxygen in both groups
6. Incidence of all complications associated with the analgesic techniques in both groups
7. Incidence of nausea and/or vomiting within the first 48 hours after surgery in both groups
8. Use of blood products in all groups
Overall trial start date
01/07/2009
Overall trial end date
01/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. American Society of Anaesthesiologists (ASA) class I - IV
2. Patients able to give written informed consent
3. Patients requiring operative repair of fractured neck of femur
4. Patients aged 18 years and over, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients - 40 in first part of study and 60 in second part of study.
Participant exclusion criteria
1. History of dementia or difficulty in obtaining consent
2. History of allergy to any of the medications used in the study
Recruitment start date
01/07/2009
Recruitment end date
01/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's University Belfast
Belfast
BT12 6BJ
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Royal Group of Hospitals
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Belfast Health and Social Care Trust (UK) (ref: RGHT 000559)
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
Basic results (scientific)
Publication list