- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02233309
A Prospective Observational Study of Epidural Pressures During Caudal Epidural in the Pediatric Population
Epidural Pressure Changes Following Caudal Blockade: A Prospective Observational Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
After approval of the Internal Review Board, the patients and families will be given the opportunity to participate in the proposed research study if inclusion criteria are met. The patient/family will sign the anesthesia consent form, as per protocol, by initialing the box at the bottom that states 'I do want, if indicated, regional anesthetic techniques employed for anesthetic maintenance and/or port operative pain relief for my child.' The primary anesthesia team (anesthesiologist/CNRA/resident) will be made aware that the need for a pressure transducer for the caudal epidural injection will be required and that a member of the research team will be documenting pressures during the procedure. Premedication with midazolam will be at the discretion of the attending anesthesiologist covering the case. Anesthesia induction may be performed with either intravenous medications or mask inhalation at the attending anesthesiologist's discretion; however no narcotics will be administered during induction, as is common when a caudal epidural is utilized for post-operative pain control. The airway will be secured using an oral endotracheal tube or laryngeal mask airway (LMA).
The single shot caudal epidural block with pressure monitoring will be performed by one of the study investigators. Ropivicaine/Bupivacaine 0.125-0.25% will be used as the local anesthetic for the caudal epidural with a total dose not to exceed 1 ml/kg. Pressure transduction will be constantly in place, with pressures being recorded by a research nurse: 1) prior to entering the epidural space, but after needle introduction under the skin, 2) after loss of resistance upon entering the epidural space, 3) at 5 second intervals during injection of the 1 mL/kg bolus of local anesthetic 4) continuing with pressure monitoring for an additional minute, in 10 second increments, after the injection is completed. Following placement of the block, a band-aidwill be placed, where appropriate, and the patient will be prepped for the surgical procedure. The primary anesthesia team will continue delivering the general anesthetic for the remainder of the case. Maintenance anesthesia will be carried out per our usual routine.
Upon completion of the surgical procedure, the patient's airway device will be removed and the patient will be transferred to the post-anesthesia care unit (PACU). In the PACU, the principal or co-investigator will review the patient's treatment needs for pain in the PACU to determine whether the block was efficacious; fentanyl 0.5 µg/kg, or the morphine-equivalent dose, will be administered as necessary based on the pain assessment. The patients will be discharged from PACU when discharge criteria are met per the Aldrete score.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ohio
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Columbus, Ohio, États-Unis, 43205
- Nationwide Children's Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- ASA physical status I or II
- Weight ≥ 3 kilograms
- Undergoing a lower abdominal/pelvic or urologic procedure where caudal epidural anesthesia is a beneficial adjunct
Exclusion Criteria:
- Co-morbid diseases (cardiac, pulmonary, neurological disease)
- Patients with sacral deformities contraindicating a caudal epidural
- Use of therapeutic dose anticoagulants or presence of a bleeding disorder
- Other co-existing conditions would preclude the use of neuraxial blockade
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Monitoring of pressures during caudal anesthesia
Patients receiving caudal anesthesia as standard of care for a surgical procedure. Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study. |
The caudal itself is a separate procedure not covered by this observational study.
This study simply attaches a monitoring device to the needle used for the caudal to measure pressures.
The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pressure in the Caudal Epidural Space
Délai: Immediately post bolus
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After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.
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Immediately post bolus
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jessica Goeller, MD, Nationwide Children's Hospital
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
Autres numéros d'identification d'étude
- IRB14-00119
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 .
Essais cliniques sur Anesthésie caudale
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Kasr El Aini HospitalComplété
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Lagos State UniversityInconnue
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Gangnam Severance HospitalComplétéBloc péridural caudalCorée, République de
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Asan Medical CenterComplétéBloc péridural caudalCorée, République de
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Yonsei UniversityComplétéBloc caudal pour l'analgésie postopératoireCorée, République de
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Prof. Dr. Cemil Tascıoglu Education and Research...RecrutementBloc caudal | Diamètre de la gaine du nerf optiqueTurquie
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Kasr El Aini HospitalComplétéEfficacité du bloc caudal sur le tonus musculaire du sphincter anal peropératoireEgypte
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Tanta UniversityComplétéBloc caudal | Pédiatrie | Bloc plan de l'érecteur sacré du rachis | Chirurgies du pénisEgypte
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University of JordanComplétéLa douleur | Anesthésie pédiatrique | Anesthésie | Bloc caudal | Chirurgies abdominalesJordan