The effect of the use of fasica iliaca nerve blockade on patient positioning for spinal anaesthesia and the effect of continuous nerve blockade on post-operative pain and mobility outcomes in patients with hip fractures
| ISRCTN | ISRCTN07083722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07083722 |
| Secondary identifying numbers | RGHT000559 |
- Submission date
- 30/09/2009
- Registration date
- 14/10/2009
- Last edited
- 07/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Scientific
Department of Anaesthetics & Intensive Care Medicine
Queen's University Belfast
2nd Floor, Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Study information
| Study design | Randomised controlled double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Health and Social Care Research Ethics Committee (HSC REC 1) (Northern Ireland), 18/04/2008, ref: 08/NIR01/20 |
| Health condition(s) or problem(s) studied | 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 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 |
| Primary outcome measure | 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 study start date | 01/07/2009 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 patients - 40 in first part of study and 60 in second part of study. |
| Key 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 |
| Key exclusion criteria | 1. History of dementia or difficulty in obtaining consent 2. History of allergy to any of the medications used in the study |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Queen's University Belfast
Belfast
BT12 6BJ
United Kingdom
BT12 6BJ
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Group of Hospitals
Grosvenor Road
Belfast
BT12 6BJ
Northern Ireland
United Kingdom
| Website | http://www.belfasttrust.hscni.net |
|---|---|
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
Belfast Health and Social Care Trust (UK) (ref: RGHT 000559)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/03/2017: No publications found, verifying study status with principal investigator.
