Clinical trial NCT02540837: Obturator and Femoral Nerve Block in Patients With Hip Fracture
Official title: Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hip Fractures
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.

With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.

The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.

Detailed description: A higher number than expected of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.

With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.

The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.

Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of hip fracture
* Age ≥ 55 years
* Mentally capable of comprehending and using verbal pain score
* Mentally capable of differentiating between pain from the fractured hip and pain from other locations
* Mentally capable of understanding the given information
* Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
* Verbal numeric pain scale score (NRS 0-10) \> 5 with a dynamic test OR NRS \> 3 at rest
* Patients informed consent

Exclusion Criteria:

* Hip fracture not confirmed by x-ray
* Weight \< 40 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

Primary outcomes:
measure: Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
timeFrame: 30 minutes
Secondary outcomes:
measure: Median pain score (NRS 0-10)
timeFrame: 30 minutes
measure: Median change in pain score (NRS 0-10)
timeFrame: 30 minutes
measure: Course in pain reduction
timeFrame: 30 minutes
measure: Time to sufficient analgesia
timeFrame: 30 minutes
measure: Frequency of anesthesia in the skin area of the saphenous nerve
timeFrame: 30 minutes
measure: Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
timeFrame: 30 minutes
measure: Localization of the worst pain before block
timeFrame: 0 minutes
measure: Localization of the worst pain after block
timeFrame: 30 minutes
measure: Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
timeFrame: 5 minutes
measure: Satisfaction (0-10, 0= very unsatisfactory)
timeFrame: 30 minutes
measure: Frequency of ultrasound visualization of femoral nerve
timeFrame: 5 minutes
measure: Frequency of ultrasound visualization of obturator injection site
timeFrame: 5 minutes
measure: Time spend on femoral nerve block
timeFrame: 5 minutes
measure: Time spend on obturator nerve block
timeFrame: 5 minutes
measure: Total morphine equivalent dose of opioid from the time of nerve block to operation
timeFrame: Approximately 24 hours in average
measure: Total morphine equivalent dose of opioid/time from the time of nerve block to operation
timeFrame: Approximately 24 hours in average
measure: Total morphine equivalent dose of opioid in the first 10 hours after nerve block
timeFrame: 10 hours
measure: Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
timeFrame: 10 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Thomas F. Bendtsen, Ph.d.
role: STUDY_DIRECTOR
References: