Pain and mobility following hip fracture in the elderly MedDRA version: 13.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 13.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 13.1 Level: PT Classification code 10020100 Term: Hip fracture System Organ Class: 10022117 - Injury, poi
Conditions
Interventions
Trade Name: Chirocaine
Product Name: Chirocaine
Product Code: Chirocaine
Pharmaceutical Form: Solution for injection
Trade Name: Naropin 2mg/ml solution for infusion
Product Name: Naropin
Product Cod
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed