Randomised controlled trial of Femoral Nerve Blockade for fractured femurs
| ISRCTN | ISRCTN48754612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48754612 |
| Secondary identifying numbers | SDHCT03/02/002; NRR Pub. ID: N0224122747 |
- Submission date
- 04/07/2006
- Registration date
- 08/08/2006
- Last edited
- 05/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Carlisle
Scientific
Scientific
Anaesthetics Department
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
Study information
| Study design | Randomised, double blind, placebo controlled 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 | |
| Study acronym | FNB study |
| Study objectives | To determine whether local anaesthetic blockade of the femoral nerve reduces pain from fractured proximal femurs. |
| Ethics approval(s) | South Devon Research Ethics Committee (formerly Torbay REC) approval gained on 14th February 2003 (reference number: 36/08/02). |
| Health condition(s) or problem(s) studied | Fractured proximal femurs |
| Intervention | Local anaesthetic blockade of the femoral nerve (0.5% bupivacaine) versus placebo (0.9% sterile saline) in patients with fractured proximal femurs. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure | To assess the quality of anaesthesia provided by systemic opioids alone or combined with femoral nerve blockade in two otherwise equivalent groups by measuring pain scores and levels of systemic opioid administration required. |
| Secondary outcome measures | 1. To assess mental function using a standard ten point scale (Abbreviated Mental Test Score [AMTS]) and a 30 point scale (Mini Mental State Examination [MMSE]) before and after the operation, comparing the two groups 2. To assess mobility and function, using a modified Physiotherapy Functional Mobility Profile (PFMP) and achievement of activities for daily living score (MIMS), before and after the operation, comparing the two groups 3. To monitor the lengths of stay in the two groups 4. To monitor the incidence of death in the two groups at 30 days and 90 days 5. To monitor the levels and incidence of infections to the wound, prosthesis and/or catheter post operatively |
| Overall study start date | 20/02/2004 |
| Completion date | 30/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 268 |
| Key inclusion criteria | 1. Aged over 18 years 2. Fractured proximal femur 3. Capable of informed consent 4. Written informed consent obtained |
| Key exclusion criteria | 1. Documented allergy to bupivacaine 2. Infection at the site of catheter placement 3. Aged under 18 years 4. Unable to give informed consent 5. Refusal to give informed consent |
| Date of first enrolment | 20/02/2004 |
| Date of final enrolment | 30/10/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetics Department
Torquay
TQ2 7AA
United Kingdom
TQ2 7AA
United Kingdom
Sponsor information
South Devon Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
England
United Kingdom
| Website | http://www.sdhct.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/05374b979 |
Funders
Funder type
Charity
Torbay Medical Research Fund
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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2007 | Yes | No |
