Morphine use after blocking the nerve of the leg with medication.

Phase 1

Conditions: Pain in proximal femur fractures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-004698-42-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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%

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>2. To assess if the ultrasound guide FICB with levobupivacaïne will lead to different pain scores during bed to bed transfer.<br>3. To assess the influence of the ultrasound guided FICB with levobupivacaïne on the occurrence of minor adverse adverse events:<br>Vomiting<br>Administration of antiemetics<br>Delirium<br>Bradypnea <br>Desaturation <br>Sedation<br>4. To assess the influence of the ultrasound guided FICB with levobupivacaïne on the length of hospital stay.<br>5. Influence of age on morphine consumption ;Primary end point(s): Operation<br>Death<br>Withdrawal from study;Timepoint(s) of evaluation of this end point: 3 - 24 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Operation<br>Death<br>Withdrawal from study<br>Discharge from hospital;Timepoint(s) of evaluation of this end point: 1- 30 days