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Regional Anesthesia and Analgesia Techniques in Obese Patients

12. december 2019 opdateret af: Emine Aysu Salviz, MD, Istanbul University

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

Ukendt

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

Observationel

Tilmelding (Forventet)

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Istanbul, Kalkun, 34093
        • Rekruttering
        • Istanbul University
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Meltem M Guler, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Any patient eligible for regional anesthesia/analgesia procedures

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The difficulty of block performance
Tidsramme: through the block performance, within 5-10 minutes
0: easy, 1: difficult, 2: very difficult
through the block performance, within 5-10 minutes

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
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: through the block performance, within 5-10 minutes
Yes/No
through the block performance, within 5-10 minutes
The requirement of adding rescue block
Tidsramme: through the block performance, within 5-10 minutes
Yes/No
through the block performance, within 5-10 minutes
Block performance duration
Tidsramme: 0-30 minutes
Time period
0-30 minutes
The number of needle direction
Tidsramme: through the block performance, within 5-10 minutes
Number
through the block performance, within 5-10 minutes
The requirement of conversion to general anesthesia
Tidsramme: 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
Tidsramme: through the block performance, within 5-10 minutes
Yes/No
through the block performance, within 5-10 minutes
Adverse effect/complication rate
Tidsramme: 1 week
Yes/No
1 week
Block success
Tidsramme: 0-30 minutes
Yes/No
0-30 minutes
Patient satisfaction
Tidsramme: 1 week
0-3 (0: not satisfied...3: very satisfied)
1 week
Patient's request for a similar technique next time
Tidsramme: 1 week
Yes/No
1 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Emine A Salvız, M.D., Istanbul University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2019

Primær færdiggørelse (Forventet)

20. maj 2020

Studieafslutning (Forventet)

1. oktober 2020

Datoer for studieregistrering

Først indsendt

4. december 2019

Først indsendt, der opfyldte QC-kriterier

12. december 2019

Først opslået (Faktiske)

13. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

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Kliniske forsøg med Regional anesthesia/analgesia techniques

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