Analgesic effect of a supplemental nerve block i patients with hip fracture

Phase 1

Conditions: Pain in patients with hip fracture
MedDRA version: 17.1Level: LLTClassification code 10017284Term: Fractured femoral neckSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-000078-36-DK

Lead Sponsor: Thomas Fichtner Bendtsen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Clinical suspicion of hip fracture
Successful sensory effect of femoral nerve block
Age = 55 years
Mentally capable of comprehending and using verbal pain score and distinguish between pain from the fractured hip and pain from other location.
Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
Possible visualization of necessary structures with ultrasound
Verbal pain score (0-10) > 3 at rest or > 5 with passive leg raise 30 minutes after femoral nerve block
Patients informed consent
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 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

Exclusion Criteria

Hip fracture not confirmed by x-ray
Weight < 45 kg
Patient has previously been included in this trial
If the patient wishes to be excluded
Allergy to local anesthetics or adrenocortical hormone
Visible infection in the area of the point of needle injection

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the trail is to investigate if supplementing an insufficient femoral nerve block with an obturator nerve block has analgesic effect in patients with hip fracture;Secondary Objective: Succesrate of possible nerve block<br>Time use to complete the nerve block<br>Time to analgesia;Primary end point(s): Frequency of patients with sufficient analgesia 20 minutes after a supplemental obturator nerve block compared to placebo;Timepoint(s) of evaluation of this end point: 20 minutes

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time spend from the beginning of the ultrasound scanning to the end of injection<br>Frequency of possible visualization of necessary structures with ultrasound i order to make the nerve block<br>Time from the end of injection to sufficient analgesia;Timepoint(s) of evaluation of this end point: 0 minutes<br>20 minutes