Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT 000675
Study information
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
Acronym
Study hypothesis
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
Health and Social Care Research Ethics Committee (HSC REC 2) (Northern Ireland) approved on the 28th July 2009 (ref: 09/NIR02/39)
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 below to request a patient information sheet
Condition
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 names
Levobupivacaine
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
31/08/2009
Overall trial end date
05/02/2010
Reason abandoned
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 - 30 in each group (Only 60 actually recruited)
Participant 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
Recruitment start date
31/08/2009
Recruitment end date
05/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthetics and Intensive Care Medicine
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Belfast Health and Social Care Trust (UK) (ref: RGHT 000675)
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