ISRCTN07083722.

Trial name or title	The effect of the use of fascia iliaca nerve blockade on patient positioning for spinal anaesthesia and the effect of continuous nerve blockade on postoperative pain and mobility outcomes in patients with hip fractures
Methods	RCT Double‐blind Approved by the ethics committee: Health and Social Care Research Ethics Committee (HSC REC 1) (Northern Ireland) approved on 18th of April 2008 (ref: 08/NIR01/20) Funding: governmental: Belfast Health and Social Care Trust (UK) (ref: RGHT 000559)
Participants	Target number of participants 100 participants ‐ 40 in first part of study and 60 in second part of study Inclusion criteria: ASA physical status class I‐IV, able to give written informed consent, requiring operative repair of fractured neck of femur, aged 18 years and over, either sex Exclusion criteria: history of dementia or difficulty in obtaining consent, history of allergy to any of the medications used in the study
Interventions	Treatment group: fascia iliaca block for positioning before spinal anaesthesia and continuous infusion after surgery Part 1: Participants randomized to receive fascia iliaca compartment block with 2 mg/kg 1% lignocaine or conventional sedation with 0.2 mg/kg IV ketamine and 0.025 mg/kg IV midazolam. At completion of surgery, a fascia iliaca block with 1 mg/kg 0.25% levobupivacaine will be performed in all participants Part 2: participants randomized to receive a preoperative fascia iliaca block with 1 mg/kg of 0.25% levobupivacaine or 2 mg/kg of 1% lignocaine. After administration of fascia iliaca block, a catheter will be inserted below the fascia iliaca and secured in place. Participants will be reviewed in the postoperative period and bolus doses of 0.125% levobupivacaine will be administered through the fascia iliaca block catheter if visual analogue scale is greater than 4. The catheter will be removed no longer than 24 hours after surgery Control group: no block
Outcomes	Primary outcome measures: ‐ Part 1: comparison of pain score at rest and positioning for spinal anaesthesia in participants who have received a fascia iliaca compartment block or conventional sedation Part 2: comparison between postoperative pain scores among participants receiving fascia iliaca blockade with lignocaine or levobupivacaine, and effects of bolus top‐up doses of low‐dose levobupivacaine on pain scores Secondary outcome measures: length of time to first request of additional analgesia, level of assistance required for transfer from sitting to standing position, incidence and severity of motor blockade, time to mobilization with walking aid, measurement of oxygen saturations without supplemental oxygen in both groups, incidence of all complications associated with analgesic techniques in both groups, incidence of nausea and/or vomiting within first 48 hours after surgery in both groups, use of blood products in all groups
Starting date	01/07/2009
Contact information	Ms Rosemary Hogg Department of Anaesthetics & Intensive Care Medicine, Queen's University Belfast, 2nd Floor, Mulhouse Building, Grosvenor Road Belfast, BT12 6BJ, United Kingdom
Notes	Completed Protocol/serial number: RGHT000559 http://www.belfasttrust.hscni.net