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
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 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 below to request a patient information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levobupivacaine |
| Primary outcome measure | 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 study start date | 31/08/2009 |
| Completion date | 05/02/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 - 30 in each group (Only 60 actually recruited) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 31/08/2009 |
| Date of final enrolment | 05/02/2010 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Department of Anaesthetics and Intensive Care Medicine
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Grosvenor Road
Belfast
BT12 6BA
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 000675)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
