Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties
Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties: A Prospective, Randomised, Double Blind Study
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Scalp blocks with local anaesthetic agents along with general anaesthesia provides intraoperative and postoperative analgesia by blunting the hemodynamic responses to noxious stimuli. The transversus abdominis plane "TAP" block, a regional anaesthesia technique that provides analgesia following abdominal surgery. It involves a single large bolus injection of local anaesthetic into an anatomical space between the internal oblique and transversus abdominis muscles.
Ropivacaine is less cardio toxic, less arrhythmogenic, less toxic to central nervous system (CNS) than bupivacaine, and it also has intrinsic vasoconstrictor property. Clonidine is an alpha-2 receptor agonist, which has a known property of reducing requirement of analgesics in the perioperative period.
This study aimed to assess the efficacy of scalp block and TAP block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Telangana
-
Secunderabad, Telangana, Inde, 500003
- Yashoda Hospitals
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Patients undergoing Abdominal bone flap replacement.
Exclusion Criteria:
- Motor and comprehensive aphasia,
- Disoriented mental state or Inability to follow commands.
- Hypersensitivity to amide local anesthetics,
- Bone flap site infection
- Coagulation disorders
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Scalp & TAP Block (Group T)
Group T received 0.2% Ropivacaine + clonidine 1µg/kg mixture, for ipsilateral scalp block (10ml),TAP block under USG guidance (20ml) and intravenous saline 0.1ml/kg/hr (sham infusion) for continuous infusion.
|
Scalp block is provided by injecting local anaesthetic in the scalp at specific areas to block 6 nerves which are responsible for sensory innervation of the scalp - Supraorbital and supratrochlear nerves, Zygomaticotemporal nerve, Auriculotemporal nerve, Greater and lesser occipital nerves.
The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1).
It is usually accomplished by a single bolus injection into the transversus abdominis plane through the lumbar triangle of Petit and can be accomplished either by blind landmark based technique or alternatively under ultrasound guidance (as in this study).
Autres noms:
|
|
Comparateur actif: Intravenous Fentanyl (Group C)
Group C received saline, for ipsilateral scalp block (10ml) and TAP block under USG guidance (20ml) and I.V fentanyl 1 µg/kg/hr as analgesic.
|
Fentanyl is a commonly used opioid drug administered for analgesia in the perioperative period.
It may be used as either intermittent bolus administration or continuous infusion or a combination of the two.
Usual infusion doses range from 1-2 microgram/kg/hr, which may be titrated based on intraoperative haemodynamics or postoperative patient reported pain scores.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in Postoperative Rescue Analgesia requirement between groups
Délai: Measured at 1, 6 and 24 hours postoperatively.
|
Postoperative rescue analgesia (Inj. paracetamol 1gm I.V) if patient reported pain measured by visual analogue score was ≥ 4. Visual analogue scale (VAS) is a self reported score for estimation of pain which ranges between 1 (no pain) to 10 (worst possible pain). VAS score interpretation: No pain - 1, Mild pain <4, Moderate pain 4-7, Severe pain >7, Worst possible pain =10. |
Measured at 1, 6 and 24 hours postoperatively.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in intraoperative trend of Heart rate between groups
Délai: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
|
Heart rate measured intraoperatively will be compared between the groups.
|
Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
|
|
Difference in intraoperative trend of Systolic blood pressure between groups
Délai: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
|
Systolic blood pressure measured intraoperatively will be compared between the groups.
|
Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
|
|
Difference in intraoperative trend of Diastolic blood pressure between groups
Délai: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
|
Diastolic blood pressure measured intraoperatively will be compared between the groups.
|
Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
|
|
Difference in patient reported postoperative pain
Délai: Measured at 1, 6 and 24 hours postoperatively.
|
Postoperative pain measured by measured by visual analogue scoring system (VAS). Range: 1-10. No pain - 1, Mild pain <4, Moderate pain 4-7, Severe pain >7, Worst possible pain =10. |
Measured at 1, 6 and 24 hours postoperatively.
|
Collaborateurs et enquêteurs
Parrainer
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
- Maladies du système nerveux
- Manifestations neurologiques
- Manifestations neurocomportementales
- Troubles de la perception
- Agnosie
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Anesthésiques intraveineux
- Anesthésiques, général
- Anesthésiques
- Analgésiques, Opioïdes
- Stupéfiants
- Adjuvants, Anesthésie
- Fentanyl
Autres numéros d'identification d'étude
- DNBT-61/2017
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .