- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
-
-
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Istanbul, Tacchino, 34093
- Reclutamento
- Istanbul University
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Contatto:
- Emine A Salvız, M.D.
- Numero di telefono: +905325225599
- Email: aysusalviz@gmail.com
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Contatto:
- Meltem M Guler, M.D.
- Numero di telefono: +905531863775
- Email: meltemmervek@gmail.com
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Investigatore principale:
- Meltem M Guler, M.D.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso-Crossover
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
Obese patients
Body mass index > 30 kg/m2
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Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery
|
Non-obese patients
Body mass index < 30 kg/m2
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Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The difficulty of block performance
Lasso di tempo: through the block performance, within 5-10 minutes
|
0: easy, 1: difficult, 2: very difficult
|
through the block performance, within 5-10 minutes
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The experience of the anesthesiologist
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
The requirement of adding rescue block
Lasso di tempo: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
Block performance duration
Lasso di tempo: 0-30 minutes
|
Time period
|
0-30 minutes
|
The number of needle direction
Lasso di tempo: through the block performance, within 5-10 minutes
|
Number
|
through the block performance, within 5-10 minutes
|
The requirement of conversion to general anesthesia
Lasso di tempo: 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
Lasso di tempo: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
|
Adverse effect/complication rate
Lasso di tempo: 1 week
|
Yes/No
|
1 week
|
Block success
Lasso di tempo: 0-30 minutes
|
Yes/No
|
0-30 minutes
|
Patient satisfaction
Lasso di tempo: 1 week
|
0-3 (0: not satisfied...3: very satisfied)
|
1 week
|
Patient's request for a similar technique next time
Lasso di tempo: 1 week
|
Yes/No
|
1 week
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Emine A Salvız, M.D., Istanbul University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2019/664
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