Condition category
Surgery
Date applied
30/09/2009
Date assigned
14/10/2009
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 & Intensive Care Medicine
Queen's University Belfast
2nd Floor
Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGHT000559

Study information

Scientific title

Comparison of fascia iliac compartment block with conventional sedation to facilitate the positioning of patients with fractured neck of femur for spinal anaesthesia and the effect of nerve blockade on post-operative pain and mobility: a randomised double-blind controlled study

Acronym

Study hypothesis

Part 1: Does the use of single shot fascia iliaca blockade reduce pain on patient positioning for spinal anaesthesia when compared with a standard sedation regime?
Part 2: Does the use of post-operative bolus dose fascia iliaca blockade improve pain and mobility outcomes in patients undergoing operative repair of fractured neck of femur?

Ethics approval

Health and Social Care Research Ethics Committee (HSC REC 1) (Northern Ireland) approved on the 18th April 2008 (ref: 08/NIR01/20)

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

Operative repair of fractured neck of femur

Intervention

Part 1:
Patients randomised to receive either fascia iliaca compartment block (FICB) with 2 mg/kg 1% lignocaine or conventional sedation with 0.2 mg/kg intravenous (iv) ketamine and 0.025 mg/kg iv midazolam. At the end of surgery, a FICB using 1 mg/kg 0.25% levobupivacaine will be performed in all patients.

Part 2:
Patients will be randomised to receive a pre-operative FICB using either 1 mg/kg 0.25% levobupivacaine or 2 mg/kg 1% lignocaine. After administration of FICB a catheter will be inserted below the fascia iliaca and secured in place. Patients will be reviewed in the post-operative period and bolus doses of 0.125% levobupivacaine administered through the FICB catheter if Visual Analogue Scale (VAS) is greater than 4. The catheter will be removed no longer than 24 hours after surgery.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Part 1: Comparison of VAS score on rest and positioning for spinal anaesthesia in patients who have received either a fascia iliaca compartment block or convention sedation.
Part 2: Comparision between post-operative VAS scores in patients receiving fascia iliaca blockade with either lignocaine or levobupivacaine and the effect of bolus top-up doses of low dose levobupivacaine on VAS scores.

Secondary outcome measures

1. Length of time to first request of additional analgesia
2. The level of assistance required for transfer from the sitting to the standing position
3. Incidence and severity of motor blockade
4. Time taken to mobilisation with walking aid
5. Measurement of oxygen saturations without supplemental oxygen in both groups
6. Incidence of all complications associated with the analgesic techniques in both groups
7. Incidence of nausea and/or vomiting within the first 48 hours after surgery in both groups
8. Use of blood products in all groups

Overall trial start date

01/07/2009

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. American Society of Anaesthesiologists (ASA) class I - IV
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

100 patients - 40 in first part of study and 60 in second part of study.

Participant exclusion criteria

1. History of dementia or difficulty in obtaining consent
2. History of allergy to any of the medications used in the study

Recruitment start date

01/07/2009

Recruitment end date

01/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthetics & Intensive Care Medicine
Belfast
BT12 6BJ
United Kingdom

Sponsor information

Organisation

Belfast Health and Social Care Trust (UK)

Sponsor details

Royal Group of Hospitals
Grosvenor Road
Belfast
BT12 6BJ
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 000559)

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