Comparison of the post-operative pain relief provided by the administration of either a femoral nerve block or fascia iliaca compartment block at one of two different doses in patients undergoing surgery for hip fracture

ISRCTN	ISRCTN51569968
DOI	https://doi.org/10.1186/ISRCTN51569968
Protocol serial number	RGHT 000675
Sponsor	Belfast Health and Social Care Trust (UK)
Funder	Belfast Health and Social Care Trust (UK) (ref: RGHT 000675)

Submission date: 14/08/2009
Registration date: 01/10/2009
Last edited: 12/06/2014

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Injury, Occupational Diseases, Poisoning

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 and Intensive Care Medicine
Queen's University Belfast
2nd Floor, Mulhouse Building
Grosvenor Road
Belfast
BT12 6BA
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 iliaca compartment block or femoral nerve block using levobupivacaine for post-operative analgesia after operative repair of femoral neck fracture - dose response study: a randomised controlled double-blind trial
Study objectives	Is there a significant difference in post-operative pain scores in patients who have received either a femoral nerve block or fascia iliaca compartment block at one of two different doses after operative repair of hip fracture?
Ethics approval(s)	Health and Social Care Research Ethics Committee (HSC REC 2) (Northern Ireland) approved on the 28th July 2009 (ref: 09/NIR02/39)
Health condition(s) or problem(s) studied	Fractured neck of femur
Intervention	Patients will be randomised to four groups - all blocks will be performed under ultrasound guidance: Group I: Fascia iliaca compartment block at a dose of 1 mg/kg levobupivacaine Group II: Fascia iliaca compartment block at a dose of 1.5 mg/kg levobupivacaine Group III: Femoral nerve block at a dose of 1 mg/kg levobupivacaine Group IV: Femoral nerve block at a dose of 1.5 mg/kg levobupivacaine After administration of the nerve block, all patients will receive spinal anaesthesia with surgery then continuing as normal. Added 09/08/2011: Trial closed early due to low recruitment - 60 patients recruited in total.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Levobupivacaine
Primary outcome measure(s)	Comparison of post-operative pain scores after one of two nerve blocks using one of two doses of the local anaesthetic following operative repair of fractured neck of femur. A post-operative assessment will be performed in the recovery room and at 4, 24 and 48 hours post-procedure. Pain scores will also be recorded by nursing staff whilst assessing routine observations.
Key secondary outcome measure(s)	Assessed at 4, 24 and 48 hours post-operatively: 1. Incidence of motor blockade 2. Post-operative analgesia requirements and time to first request of post-operative analgesia 3. Ability to mobilise on the first post-operative day 4. Incidence of any adverse events 5. One and three month mortality
Completion date	05/02/2010
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. American Society of Anaesthesiologists (ASA) class I - III 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 allergy to any of the medications used in the study 2. Patients with a history of dementia or difficulty in providing informed consent 3. Patients with a history of significant neurological impairment of one or both of the lower limbs 4. Patients with a pathological fracture of the neck of femur 5. Patients suffering from severe hypotension such as cardiogenic or hypovolaemic shock or with a serious cardiac arrhythmia
Date of first enrolment	31/08/2009
Date of final enrolment	05/02/2010

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

Department of Anaesthetics and Intensive Care Medicine

Belfast
BT12 6BA
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?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes