- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03550677
Effect of Intraoperative Ankle Nerve Blocks on Postoperative Discharge in Patients Undergoing Orthopaedic Foot Surgery
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
After written informed consent obtained from patients, patients will be randomly assigned to placebo group (Group I) and block group (group II) using sealed envelope method. IV venous catheter will be inserted and saline or Ringer's Lactate solution will be infused to patients for prehydration.0.1-0.5 mg/kg midazolam will be given for premedication. After arriving into OR, the patients will be monitored with ECG, pulse oximetry and noninvasive blood pressure. Anesthesia will be induced using 2-2,5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10 mg-20 mg rocuronium, and a proper size laryngeal mask airway (LMA) will be placed to secure the airway. The lungs will be ventilated with a mixture of 50% air + 50% oxygen. Propofol and remifentanil based total intravenous anesthesia (TIVA) technique will be used for the maintenance of anesthesia. Tenoxicam 20 mg will be used for preemptive analgesia, cefazolin 25 mg/kg for antibiotic prophylaxis, ranitidine 50 mg for gastric protection, and metoclopramide 10 mg for postoperative nausea and vomiting. Acetaminophen 10-15 mg/kg IV will be given for postoperative analgesia at the time of wound closure.
At the end of the operation, an ankle nerve block will be performed in group II patient using a mixture of 2%lidocaine and 10 ml of bupivacaine and the same amount placebo in group I (placebo group) under the guidance of peripheral nerve stimulator. The anesthesia will be discontinued and LMA will be removed. The patients will be transferred from postoperative care unit to the ward after they were eligible for discharge according to modified Aldrete scoring system.
Postoperative analgesia will be evaluated by a study member who is blinded to study groups using visual analog scale (VAS). Acetaminophen 1000 mg p.o. were given at 8 hours intervals and an intravenous patient-controlled analgesia containing 3 mg/ml of tramadol will be used for postoperative pain therapy. Pethidine 0.5 mg/kg IV will be used for rescue analgesic if VAS score is greater than 3.
The motor block will be evaluated using Bromage scale, sensorial block with pin-prick test. The duration of motor and sensorial block, postoperative VAS scores, the time to the first analgesic requirement, total analgesic consumption and vital parameters will be recorded. Patient's satisfaction will be evaluated using 3 point scale between the scores 0 and 2. 0= poor 1= fair 2=satisfied Postoperative discharge times will be recorded.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Altındag
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Ankara, Altındag, Turquie, 06110
- University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
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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:
- Patient's acceptance,
- American Society of Anesthesiologists physical status I-III
- elective orthopedic foot surgery
- general anesthesia
Exclusion Criteria:
- Pregnancy
- history of chronic pain therapy
- hypersensitivity to study drugs
- allergy to study drugs
- blood coagulation disorder
- anticoagulant use
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group General Anesthesia
These group patients will be monitored with ECG, pulse oximetry and noninvasive blood pressure.
Anesthesia will be induced using 2-2.5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10 mg-20 mg rocuronium and a proper size laryngeal mask airway will be placed to secure the airway.
The lungs will be ventilated with a mixture of 50% and 50% oxygen.
|
The patient will be monitored with ECG, pulse oximetry and noninvasive blood pressure.
Anesthesia will be induced using 2-2.5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10-20 mg rocuronium and proper size Laryngeal mask airway will be placed securely the airway.
Autres noms:
|
|
Expérimental: Group Ankle Block
These group patients will be monitored with ECG, pulse oximetry and noninvasive blood pressure.
Anesthesia will be induced using 2-2.5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10 mg-20 mg rocuronium and a proper size laryngeal mask airway will be placed to secure the airway.
The lungs will be ventilated with a mixture of 50% and 50% oxygen.
After than an ankle block will be performed in patient group block patients using a mixture of 5 ml of 2% lidocaine and 10 ml of 0.5 bupivacaine the same amount placebo (saline) in group placebo under the guidance of peripheral nerve stimulator then the anesthesia will be disconnected and LMA will be removed.
The patients will be transferred from postoperative care unit toward after they are eligible for discharge according to the modified scoring system.
|
The patient will be monitored with ECG, pulse oximetry and noninvasive blood pressure.
Anesthesia will be induced using 2-2.5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10-20 mg rocuronium and proper size Laryngeal mask airway will be placed securely the airway.
Autres noms:
ankle nerve block will be performed in group ankle block patients using a mixture of 5 ml of 2% lidocaine and 10 ml of 0.5% bupivacaine and same amount placebo (saline) in groups placebo under the guidance of peripheral nerve stimulator the anesthesia will be discontinued and LMA will be removed.
The patients will be transferred from postoperative care unit to the ward after they are eligible for discharge according to modified Aldrete scoring system.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative pain
Délai: 3 months
|
Postoperative pain is evaluated using Visual Analogue Scale.
|
3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
postoperative discharge times
Délai: 3 months
|
postoperative discharge times of paitnets after surgery
|
3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Ceyda Ozhan Caparlar, University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
Publications et liens utiles
Publications générales
- McLeod DH, Wong DH, Vaghadia H, Claridge RJ, Merrick PM. Lateral popliteal sciatic nerve block compared with ankle block for analgesia following foot surgery. Can J Anaesth. 1995 Sep;42(9):765-9. doi: 10.1007/BF03011173. Erratum In: Can J Anaesth 1995 Nov;42(11):1065.
- Fraser TW, Doty JF. Peripheral Nerve Blocks in Foot and Ankle Surgery. Orthop Clin North Am. 2017 Oct;48(4):507-515. doi: 10.1016/j.ocl.2017.06.008. Epub 2017 Aug 16.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
Autres numéros d'identification d'étude
- 49/07
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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