- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Istanbul, Kalkun, 34093
- Rekruttering
- Istanbul University
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Kontakt:
- Emine A Salvız, M.D.
- Telefonnummer: +905325225599
- E-mail: aysusalviz@gmail.com
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Kontakt:
- Meltem M Guler, M.D.
- Telefonnummer: +905531863775
- E-mail: meltemmervek@gmail.com
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Ledende efterforsker:
- Meltem M Guler, M.D.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Crossover
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
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
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The difficulty of block performance
Tidsramme: through the block performance, within 5-10 minutes
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0: easy, 1: difficult, 2: very difficult
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through the block performance, within 5-10 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The experience of the anesthesiologist
Tidsramme: 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
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through the Anesthesiology residency training period, within 5 years and Anesthesiology experience, within 20 years
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The requirement of changing hands with a more experienced anesthesiologist
Tidsramme: through the block performance, within 5-10 minutes
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The number of changing
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through the block performance, within 5-10 minutes
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The requirement of changing patient position
Tidsramme: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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The requirement of changing regional anesthesia/analgesia approach
Tidsramme: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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The requirement of changing needle size or length
Tidsramme: through the block performance, within 5-10 minutes
|
Yes/No
|
through the block performance, within 5-10 minutes
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The requirement of adding rescue block
Tidsramme: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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Block performance duration
Tidsramme: 0-30 minutes
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Time period
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0-30 minutes
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The number of needle direction
Tidsramme: through the block performance, within 5-10 minutes
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Number
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through the block performance, within 5-10 minutes
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The requirement of conversion to general anesthesia
Tidsramme: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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The requirement of adding another block monitorization technique
Tidsramme: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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Adverse effect/complication rate
Tidsramme: 1 week
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Yes/No
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1 week
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Block success
Tidsramme: 0-30 minutes
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Yes/No
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0-30 minutes
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Patient satisfaction
Tidsramme: 1 week
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0-3 (0: not satisfied...3: very satisfied)
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1 week
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Patient's request for a similar technique next time
Tidsramme: 1 week
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Yes/No
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1 week
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Emine A Salvız, M.D., Istanbul University
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019/664
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Regional anesthesia/analgesia techniques
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