The effect of the use of fasica iliaca nerve blockade on patient positioning for spinal anaesthesia and the effect of continuous nerve blockade on post-operative pain and mobility outcomes in patients with hip fractures

ISRCTN	ISRCTN07083722
DOI	https://doi.org/10.1186/ISRCTN07083722
Protocol serial number	RGHT000559
Sponsor	Belfast Health and Social Care Trust (UK)
Funder	Belfast Health and Social Care Trust (UK) (ref: RGHT 000559)

Submission date: 30/09/2009
Registration date: 14/10/2009
Last edited: 07/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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

Ms Rosemary Hogg
Scientific

Department of Anaesthetics & Intensive Care Medicine
Queen's University Belfast
2nd Floor, Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled double-blind trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Health and Social Care Research Ethics Committee (HSC REC 1) (Northern Ireland), 18/04/2008, ref: 08/NIR01/20
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key exclusion criteria	1. History of dementia or difficulty in obtaining consent 2. History of allergy to any of the medications used in the study
Date of first enrolment	01/07/2009
Date of final enrolment	01/09/2009

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

Queen's University Belfast

Belfast
BT12 6BJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/03/2017: No publications found, verifying study status with principal investigator.