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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Aarhus, Danemark, 8000
- Recrutement
- Aarhus University Hospital
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Contact:
- Thomas D. Nielsen, MD
- Numéro de téléphone: +45 28782877
- E-mail: thomas.dahl.nielsen@clin.au.dk
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Contact:
- Thomas F. Bendtsen, MD, Ph.d.
- Numéro de téléphone: +45 51542997
- E-mail: tfb@dadlnet.dk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Bupivacaine
Obturator nerve block
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Obturator nerve block
Autres noms:
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Comparateur placebo: Saline
Saline is injected as a placebo
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Obturator nerve block with saline(placebo)
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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.
Délai: 30 minutes
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Success rate of successful analgesia compared between the groups
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30 minutes
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Median pain score (NRS 0-10)
Délai: 30 minutes
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Median pain score 30 minutes after the nerve blocks compared between the groups
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30 minutes
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Median change in pain score (NRS 0-10)
Délai: 30 minutes
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Median change in pain score 30 minutes after the nerve blocks compared between the groups
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30 minutes
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Course in pain reduction
Délai: 30 minutes
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Course in pain reduction during the 30 minutes after the nerve blocks
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30 minutes
|
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Time to sufficient analgesia
Délai: 30 minutes
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Time from ended injection until sufficient analgesia
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30 minutes
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Frequency of anesthesia in the skin area of the saphenous nerve
Délai: 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
Délai: 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
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Localization of the worst pain before block
Délai: 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
Délai: 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)
Délai: 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)
Délai: 30 minutes
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Patient satisfaction with the pain treatment
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30 minutes
|
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Frequency of ultrasound visualization of femoral nerve
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Approximately 24 hours in average
|
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
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Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Délai: 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
Délai: 10 hours
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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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Thomas F. Bendtsen, Ph.d., Aarhus University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Blessures et Blessures
- Blessures aux jambes
- Fracture fémorale
- Blessures à la hanche
- Fractures, Os
- Fracture de la hanche
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Agents du système sensoriel
- Anesthésiques
- Anesthésiques locaux
- Bupivacaïne
Autres numéros d'identification d'étude
- protocol2_2tdn
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