- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04197752
Regional Anesthesia and Analgesia Techniques in Obese Patients
Use of Regional Anesthesia and Analgesia Techniques in Obese Patients: A Prospective Observational Study
Obesity is a health problem throughout the world and has increasingly become a widespread epidemic all over the world and also in Turkey. Anesthesia management of obese patients is challenging because of difficult airway, increased drug doses, co-morbidities, loss of anatomical landmarks and difficulties in positioning.
Neuroaxial and peripheral nerve blocks are widely used in anesthesia practice in both obese and non-obese patients undergoing different surgical operations.
In this prospective observational study, the investigators plan to enroll all patients that are applied neuroaxial or peripheral blocks during the study period. The aim of this study is to compare the differences and difficulties of regional anesthesia/analgesia techniques in obese and non-obese patients.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Obesity is a health problem throughout the world and has increasingly become a widespread epidemic all over the world and also in Turkey. Anesthesia management of obese patients is challenging because of difficult airway, increased drug doses, co-morbidities, loss of anatomical landmarks and difficulties in positioning.
On the other hand, neuroaxial and peripheral nerve blocks are widely used in anesthesia practice in both obese and non-obese patients undergoing different surgical operations.
In this prospective observational study, the investigators plan to enroll all patients that are applied neuroaxial or peripheral blocks during the study period. The difficulty of block performance, its relationship with experience, the requirement of changing hands with more experienced clinician, the requirement of changing patient position, regional anesthesia approach or needle (size and length), the requirement of adding rescue block, block success, performance duration, the number of needle direction (multiple attempts), the requirement of changing anesthesia or analgesia technique (conversion to general anesthesia), the requirement of adding another block monitorisation technique, adverse effect/complication, patient satisfaction and patient's request for a similar technique next time are all recorded both in obese and non-obese patients.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
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Istanbul, Turquie, 34093
- Recrutement
- Istanbul University
-
Contact:
- Emine A Salvız, M.D.
- Numéro de téléphone: +905325225599
- E-mail: aysusalviz@gmail.com
-
Contact:
- Meltem M Guler, M.D.
- Numéro de téléphone: +905531863775
- E-mail: meltemmervek@gmail.com
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Chercheur principal:
- Meltem M Guler, M.D.
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients eligible for regional anesthesia/analgesia
- > 18 years old
- ASA 1-3
Exclusion Criteria:
- < 18 years old
- Patient refusal for regional anesthesia/analgesia
- Patient refusal to participate in the study
- Allergic to local anesthetics
- Psychiatric diseases
- Incapable to communicate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-Crossover
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Obese patients
Body mass index > 30 kg/m2
|
Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery
|
Non-obese patients
Body mass index < 30 kg/m2
|
Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The difficulty of block performance
Délai: through the block performance, within 5-10 minutes
|
0: easy, 1: difficult, 2: very difficult
|
through the block performance, within 5-10 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The experience of the anesthesiologist
Délai: through the Anesthesiology residency training period, within 5 years and Anesthesiology experience, within 20 years
|
0: Junior resident, 1: senior resident, 2: attending anesthesiologist, 3: assoc.prof./prof.anesthesiologist
|
through the Anesthesiology residency training period, within 5 years and Anesthesiology experience, within 20 years
|
The requirement of changing hands with a more experienced anesthesiologist
Délai: through the block performance, within 5-10 minutes
|
The number of changing
|
through the block performance, within 5-10 minutes
|
The requirement of changing patient position
Délai: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
The requirement of changing regional anesthesia/analgesia approach
Délai: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
The requirement of changing needle size or length
Délai: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
The requirement of adding rescue block
Délai: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
Block performance duration
Délai: 0-30 minutes
|
Time period
|
0-30 minutes
|
The number of needle direction
Délai: through the block performance, within 5-10 minutes
|
Number
|
through the block performance, within 5-10 minutes
|
The requirement of conversion to general anesthesia
Délai: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
The requirement of adding another block monitorization technique
Délai: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
Adverse effect/complication rate
Délai: 1 week
|
Yes/No
|
1 week
|
Block success
Délai: 0-30 minutes
|
Yes/No
|
0-30 minutes
|
Patient satisfaction
Délai: 1 week
|
0-3 (0: not satisfied...3: very satisfied)
|
1 week
|
Patient's request for a similar technique next time
Délai: 1 week
|
Yes/No
|
1 week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Emine A Salvız, M.D., Istanbul University
Publications et liens utiles
Publications générales
- Franco CD, Gloss FJ, Voronov G, Tyler SG, Stojiljkovic LS. Supraclavicular block in the obese population: an analysis of 2020 blocks. Anesth Analg. 2006 Apr;102(4):1252-4. doi: 10.1213/01.ane.0000198341.53062.a2.
- Hanouz JL, Grandin W, Lesage A, Oriot G, Bonnieux D, Gerard JL. Multiple injection axillary brachial plexus block: influence of obesity on failure rate and incidence of acute complications. Anesth Analg. 2010 Jul;111(1):230-3. doi: 10.1213/ANE.0b013e3181dde023. Epub 2010 Apr 24.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (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
- 2019/664
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
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