Condition category
Injury, Occupational Diseases, Poisoning
Date applied
14/08/2009
Date assigned
01/10/2009
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rosemary Hogg

ORCID ID

Contact details

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

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

http://www.belfasttrust.hscni.net

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

Publication citations

Additional files

Editorial Notes