Pain in patients with hip fracture MedDRA version: 17.1 Level: LLT Classification code 10017284 Term: Fractured femoral neck System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Marcain-adrenalin
Product Name: Marcain-adrenalin
Pharmaceutical Form: Solution for injection
Trade Name: Dexamethasone krka
Product Name: Dexamethasone krka
Pharmaceutical Form: Solution
Sponsors
Thomas Fichtner Bendtsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical suspicion of hip fracture 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 Verbal pain score (0-10trail) = 7 with passive leg raise at the time of inclusion 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: Hip fracture not confirmed by x-ray Weight 3, 30 minutes after the nerve block Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block Patient has previously beeb included in this trial Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone Verbal pain score > 3 from other locations than the fractured hip 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 Acute inability to comprehend and use verbal pain score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Investigat the course of pain reduction until 30 minutes after the nerve block Success rate of sufficient analgesia after femoral nerve block for pain in patients with hip fracture Number of patients without cessation of analgesia at the time of operation If insufficient anesthesia of both divisions of the femoral nerve is correlated to insufficient analgesia of the fractured hip pain;Main Objective: The objective is to investigate if the addition of Dexamethasone to Bupivacaine for preoperative analgesia with a femoral nerve block in patients with hip fracture results in prolonged analgesia compared to plain Bupivacaine without Dexamethasone;Primary end point(s): Frequency of a minimum of 20 hours of analgesia or analgesia at the time of operation in patients with hip fracture after femoral nerve block with Dexamethason added to Bupivacaine compared to plain Bupivacaine;Timepoint(s) of evaluation of this end point: 20 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Frequency of a minimum of 22 hours of analgesia or analgesia at the time of operation in patients with hip fracture after femoral nerve block with Dexamethason added to Bupivacaine compared to plain Bupivacaine. Frequency of a minimum of 24 hours of analgesia or analgesia at the time of operation in patients with hip fracture after femoral nerve block with Dexamethason added to Bupivacaine compared to plain Bupivacaine. Frequency of patients who at the time of operation grade the analgesic treatment since inclusion to have been sufficient. Mean time from nerve block to need of opioid analgesia. Use of opioids by 20, 22 and 24 hours. Mean time from nerve block to verbal pain score =3 at rest. Mean time from nerve block to verbal pain score =5 with passive leg raise. Frequency af reduced cold sensation in the skin area innervated by the Saphenous nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block. Frequency af reduced cold sensation in the skin area innervated by the Rami Cutanei Anteriores Nervi Femoralis when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block. Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bipivacaine compared to plain Bupivacaine. Frequency of insufficient analgesia and frequency of absent analgesic effect after femoral nerve block with Dexamethasone added to Bipivacaine compared to plain Bupivacaine Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes Frequency af possible ultrasound visualisation af the femoral nerve ;Timepoint(s) of evaluation of this end point: 0 minutes 30 minutes 20 hours 22 hours 24 hours | — |
Countries
Denmark
Contacts
Public ContactDep. Anaesthesia and Intensive Care
Aarhus University Hospital
Outcome results
None listed