NCT04197752

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 4, 2019

Last Update Submit

December 12, 2019

Conditions

ObesityRegional Anesthesia

Keywords

ObesityNeuroaxial blocksPeripheral nerve blocksPerformanceComplication

Outcome Measures

Primary Outcomes (1)

  • The difficulty of block performance

    0: easy, 1: difficult, 2: very difficult

    through the block performance, within 5-10 minutes

Secondary Outcomes (14)

  • The experience of the 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

    through the block performance, within 5-10 minutes

  • The requirement of changing patient position

    through the block performance, within 5-10 minutes

  • The requirement of changing regional anesthesia/analgesia approach

    through the block performance, within 5-10 minutes

  • The requirement of changing needle size or length

    through the block performance, within 5-10 minutes

  • +9 more secondary outcomes

Study Arms (2)

Obese patients

Body mass index \> 30 kg/m2

Other: Regional anesthesia/analgesia techniques

Non-obese patients

Body mass index \< 30 kg/m2

Other: Regional anesthesia/analgesia techniques

Interventions

Regional anesthesia/analgesia techniquesOTHER

Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery

Non-obese patientsObese patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient eligible for regional anesthesia/analgesia procedures

You may qualify if:

  • Patients eligible for regional anesthesia/analgesia
  • \> 18 years old
  • ASA 1-3

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 16551933BACKGROUND

  • 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.

    PMID: 20418535BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Emine A Salvız, M.D.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine A Salvız, M.D.

CONTACT

+905325225599aysusalviz@gmail.com

Meltem M Guler, M.D.

CONTACT

+905531863775meltemmervek@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 13, 2019

Study Start

May 20, 2019

Primary Completion

May 20, 2020

Study Completion

October 1, 2020

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)