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
Secondary identifying numbers 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

Study designRandomised controlled double blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleComparison 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 objectivesIs 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) studiedFractured neck of femur
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Levobupivacaine
Primary outcome measureComparison 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 measuresAssessed 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 study start date31/08/2009
Completion date05/02/2010
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120 - 30 in each group (Only 60 actually recruited)
Key inclusion criteria1. 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 criteria1. 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 enrolment31/08/2009
Date of final enrolment05/02/2010

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Department of Anaesthetics and Intensive Care Medicine
Belfast
BT12 6BA
United Kingdom

Sponsor information

Belfast Health and Social Care Trust (UK)
Hospital/treatment centre

Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom

Website http://www.belfasttrust.hscni.net
ROR logo "ROR" https://ror.org/02tdmfk69

Funders

Funder type

Government

Belfast Health and Social Care Trust (UK) (ref: RGHT 000675)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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