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Randomised controlled trial of Femoral Nerve Blockade for fractured femurs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48754612
Enrollment
268
Registered
2006-08-08
Start date
2004-02-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractured proximal femurs Musculoskeletal Diseases Fractured proximal femurs

Interventions

Local anaesthetic blockade of the femoral nerve (0.5% bupivacaine) versus placebo (0.9% sterile saline) in patients with fractured proximal femurs.

Sponsors

South Devon Healthcare NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Fractured proximal femur 3. Capable of informed consent 4. Written informed consent obtained

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026