Pain in proximal femur fractures
Conditions
Interventions
Trade Name: Chirocaine
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Perineural use
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patient (>18) diagnosed with a proximal femur fracture upon arrival at the ED. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: No informed consent patient Skin infection at injection site(s) Morphine allergy Levobupivacaine allergy Operation within an hour after admission Inability to understand and quantify pain on a NRS Dementia Neurological deficit of fractured leg upon arrival at the ED Trauma with multiple fractures (more than 1) Risk of compartment syndrome of ipsilateral lower leg. Proximal femur fracture with other definitive treatment than operation Transfer to another hospital Actual morphine use Distracting pain in other location than hip Pregnancy No physician/nurse available for procedure. BMI > 40 Saturation < 90%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assess the preoperative morphine consumption in ED patients with a proximal femur fracture who received the ultrasound guided FICB with levobupivacaïne;Secondary Objective: 1. To assess if the ultrasound guide FICB with levobupivacaïne will lead to different average pain scores. 2. To assess if the ultrasound guide FICB with levobupivacaïne will lead to different pain scores during bed to bed transfer. 3. To assess the influence of the ultrasound guided FICB with levobupivacaïne on the occurrence of minor adverse adverse events: Vomiting Administration of antiemetics Delirium Bradypnea Desaturation Sedation 4. To assess the influence of the ultrasound guided FICB with levobupivacaïne on the length of hospital stay. 5. Influence of age on morphine consumption ;Primary end point(s): Operation Death Withdrawal from study;Timepoint(s) of evaluation of this end point: 3 - 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Operation Death Withdrawal from study Discharge from hospital;Timepoint(s) of evaluation of this end point: 1- 30 days | — |
Countries
Netherlands
Outcome results
None listed