Obturator and Femoral Nerve Block in Patients With Hip Fracture
Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Aarhus, Danmark, 8000
- Rekruttering
- Aarhus University Hospital
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Ta kontakt med:
- Thomas D. Nielsen, MD
- Telefonnummer: +45 28782877
- E-post: thomas.dahl.nielsen@clin.au.dk
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Ta kontakt med:
- Thomas F. Bendtsen, MD, Ph.d.
- Telefonnummer: +45 51542997
- E-post: tfb@dadlnet.dk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Bupivacaine
Obturator nerve block
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Obturator nerve block
Andre navn:
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Placebo komparator: Saline
Saline is injected as a placebo
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Obturator nerve block with saline(placebo)
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 30 minutes
|
Success rate of successful analgesia compared between the groups
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30 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Median pain score (NRS 0-10)
Tidsramme: 30 minutes
|
Median pain score 30 minutes after the nerve blocks compared between the groups
|
30 minutes
|
|
Median change in pain score (NRS 0-10)
Tidsramme: 30 minutes
|
Median change in pain score 30 minutes after the nerve blocks compared between the groups
|
30 minutes
|
|
Course in pain reduction
Tidsramme: 30 minutes
|
Course in pain reduction during the 30 minutes after the nerve blocks
|
30 minutes
|
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Time to sufficient analgesia
Tidsramme: 30 minutes
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Time from ended injection until sufficient analgesia
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30 minutes
|
|
Frequency of anesthesia in the skin area of the saphenous nerve
Tidsramme: 30 minutes
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Frequency of anesthesia in the skin area innervated by the saphenous nerve
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30 minutes
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Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Tidsramme: 30 minutes
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Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
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30 minutes
|
|
Localization of the worst pain before block
Tidsramme: 0 minutes
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Localization of the worst pain before any nerve blocks
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0 minutes
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Localization of the worst pain after block
Tidsramme: 30 minutes
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Localization of the worst pain 30 minutes after the nerve blocks
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30 minutes
|
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Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
Tidsramme: 5 minutes
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Discomfort during the nerve block procedures compared between procedures
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5 minutes
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Satisfaction (0-10, 0= very unsatisfactory)
Tidsramme: 30 minutes
|
Patient satisfaction with the pain treatment
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30 minutes
|
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Frequency of ultrasound visualization of femoral nerve
Tidsramme: 5 minutes
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Frequency of patients with possible ultrasound visualization af the femoral nerve
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5 minutes
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Frequency of ultrasound visualization of obturator injection site
Tidsramme: 5 minutes
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Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
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5 minutes
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Time spend on femoral nerve block
Tidsramme: 5 minutes
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Time spend on conducting the femoral nerve block
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5 minutes
|
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Time spend on obturator nerve block
Tidsramme: 5 minutes
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Time spend on conducting the obturator nerve block
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5 minutes
|
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Total morphine equivalent dose of opioid from the time of nerve block to operation
Tidsramme: Approximately 24 hours in average
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Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
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Approximately 24 hours in average
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Total morphine equivalent dose of opioid/time from the time of nerve block to operation
Tidsramme: Approximately 24 hours in average
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Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
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Approximately 24 hours in average
|
|
Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Tidsramme: 10 hours
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Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
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10 hours
|
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Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
Tidsramme: 10 hours
|
Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block
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10 hours
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Thomas F. Bendtsen, Ph.d., Aarhus University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- protocol2_2tdn
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