The FINOF(Femoral Nerve-Block Intervention in Neck Of Femur Fracture) Study - FINOF

• Conditions: MedDRA version: 13.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 13.1Level: PTClassification code 10020100Term: Hip fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 13.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Pain and mobility following hip fracture in the elderly

• Registration Number: EUCTR2010-023871-25-GB
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-17
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

aged 70yrs and over, resident in their own home or warden aided flat , patients who are cognitively intact [as defined by a score of seven or more on the Abbreviated 10 point Mental Test Score (AMTS) , and a prior fracture New Mobility Score of 3 or more (indicating independent indoor ambulation) .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria : prefracture hospitalisation, contraindications to femoral nerve block analgesia, regular prefracture opioid or glucocorticoid therapy, alcohol or substance abuse, morphine intolerance, and postoperative surgical restrictions for ambulation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The question to be asked is whether femoral nerve blockade, administered in the acute and early post operative phase to elderly hip fracture patients, will control pain,improve early rehabilitation and reduce opioid associated complications.;Secondary Objective: -to estimate the cost-effectiveness of femoral nerve blockade, compared to usual care from a NHS perspective. - to examine issues of compliance, acceptability to staff and patients.;Primary end point(s): Primary Outcome Measure from day 1 to day 3 post operatively: a. Cumulative ambulation score (CAS) b. Cumulative dynamic pain score post operatively