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- Registre américain des essais cliniques
- Essai clinique NCT01157546
TAP Block for Open Radical Prostatectomy.
Continuous Transversus Abdominis Plane (TAP) Block for Open Radical Prostatectomy. A Double Blind Randomized Study.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Open prostatectomy is a surgical procedure performed by urologists to excise the prostate. This is achieved by a 10-cm vertical incision starting below the umbilicus and reaching the pubic area. Patients are hospitalized for 3-4 days: one of the criteria for safe discharge includes Visual Analogue Scale (VAS) for pain below 3 at rest. For postoperative pain control, patients receive patient-controlled opioid analgesia (PCA) with morphine. The average amount of morphine used in the first 24 h varies between 30 and 50 mg. Although this technique is widely used, side effects (sedation, ileus, pruritus) are commonly encountered with opioid administration. Thus alternative analgesic techniques such as epidural analgesia and wound infiltration have been used with some success. However adverse events have also been reported with these techniques (lower limb motor block with epidural; infection wound infiltration).
In the last 10 years, a new technique, the transversus abdominis plane (TAP) block, which anesthetizes the thoracolumbar nerves (intercostal, subcostal and first lumbar nerves), has been described. The thoracolumbar nerves provide sensory innervation to the anterolateral abdominal wall. The traditional technique for TAP blocks is performed with a blunt needle in the Triangle of Petit. The latter is delineated caudally by the iliac crest, posteriorly by the latissimus muscle and anteriorly by the external oblique. Two distinct pops can be felt as the needle crosses the fascial extensions of the external oblique and the internal oblique muscle, respectively. Thus the second pop usually signifies that the needle tip has reached the TAP. Although the traditional technique has been used to provide postoperatively analgesia for bowel surgery, hysterectomy and Cesarian Section, the position of the Triangle of Petit varies greatly thus making it difficult to palpate in obese patients. In 2007, there was a study describing an ultrasound-guided technique for TAP blocks: these authors advocated using ultrasonography to locate the TAP along the mid-axillary line above the iliac crest. This ultrasound-guided technique has been subsequently used to provide postoperative analgesia for laparoscopic cholecystectomy, appendicectomy and Cesarian Section. This technique has been shown to spare opioids in the postoperative period therefore facilitating an accelerated discharge and superior pain relief.
In our institution, the TAP block, either as a single shot or as a continuous catheter infusion, is used for abdominal and urological surgery when epidural blockade is not feasible.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Quebec
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Montreal, Quebec, Canada, H3G1A4
- McGill University Health Centre, Montreal General 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:
- Age: 18 years and over
- ASA class 1, 2
- Elective open radical prostatectomy
Exclusion Criteria:
- Any history or signs of cardiac, hepatic and renal failure. Patients with raised serum LFTs and serum creatinine outside normal range
- Any chronic use of opioid analgesic
- Morbid obesity (BMI>40)
- History of allergic reactions to any of the study medications and the medications used for the trial
- Pregnancy
- Previous abdominal surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Control
group A (control) will receive a bolus of normal saline (20 mL per side) followed by a continuous infusion of normal saline (7 ml/h per side) via both TAP catheters.The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
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A bolus of normal saline (20 mL per side) followed by a continuous infusion of normal saline (7 ml/h per side.
The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
Autres noms:
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Expérimental: TAP
group B (TAP) will receive a bolus of lidocaine 1% with epinephrine 1:200 000 (20 mL per side) followed by a continuous infusion of ropivacaine 0.2% (7 mL/h per side) via TAP catheters.
The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
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A bolus of lidocaine 1% with epinephrine 1:200 000 (20 mL per side) followed by a continuous infusion of ropivacaine 0.2% (7 mL/h per side).
The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Postoperative morphine consumption
Délai: at 24 hour after surgery
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at 24 hour after surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of nausea and vomiting
Délai: at 2, 12, 24 and 48 hour after surgery
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at 2, 12, 24 and 48 hour after surgery
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VRS for pain at rest, during ambulation and coughing
Délai: at 2, 12, 24 and 48 hour after surgery
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at 2, 12, 24 and 48 hour after surgery
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Assessment of recovery
Délai: at 24 hours after the surgery and every 24 hours until patients are discharged.
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Assessment of recovery (two-minute walking test, Miles scale) and time out of bed (sitting or walking will be measured every day until hospital discharge.
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at 24 hours after the surgery and every 24 hours until patients are discharged.
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Postoperative morphine consumption
Délai: at 2, 12 and 48 hours after surgery
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at 2, 12 and 48 hours after surgery
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Franco Carli, Professor, McGill University Healt Centre, Department of Anesthesia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (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
- Signes et symptômes digestifs
- Vomissement
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-arythmie
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Agents du système sensoriel
- Anesthésiques
- Modulateurs de transport membranaire
- Anesthésiques locaux
- Bloqueurs de canaux sodiques voltage-dépendants
- Bloqueurs des canaux sodiques
- Lidocaïne
Autres numéros d'identification d'étude
- GEN-10-012
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