Regional Anesthesia and Analgesia Techniques in Obese Patients

Obesity Clinical Trial

Official title:

Use of Regional Anesthesia and Analgesia Techniques in Obese Patients: A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197752
• Other study ID #: 2019/664
• Status: Recruiting
• Start date: May 20, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2019
• Source: Istanbul University
• Contact: Emine A Salviz, M.D.
• Phone: +905325225599
• Email: aysusalviz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Regional Anesthesia

Intervention

Other:
• Regional anesthesia/analgesia techniques
Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Hanouz JL, Grandin W, Lesage A, Oriot G, Bonnieux D, Gérard 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difficulty of block performance	0: easy, 1: difficult, 2: very difficult	through the block performance, within 5-10 minutes
Secondary	The experience of the anesthesiologist	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
Secondary	The requirement of changing hands with a more experienced anesthesiologist	The number of changing	through the block performance, within 5-10 minutes
Secondary	The requirement of changing patient position	Yes/No	through the block performance, within 5-10 minutes
Secondary	The requirement of changing regional anesthesia/analgesia approach	Yes/No	through the block performance, within 5-10 minutes
Secondary	The requirement of changing needle size or length	Yes/No	through the block performance, within 5-10 minutes
Secondary	The requirement of adding rescue block	Yes/No	through the block performance, within 5-10 minutes
Secondary	Block performance duration	Time period	0-30 minutes
Secondary	The number of needle direction	Number	through the block performance, within 5-10 minutes
Secondary	The requirement of conversion to general anesthesia	Yes/No	through the block performance, within 5-10 minutes
Secondary	The requirement of adding another block monitorization technique	Yes/No	through the block performance, within 5-10 minutes
Secondary	Adverse effect/complication rate	Yes/No	1 week
Secondary	Block success	Yes/No	0-30 minutes
Secondary	Patient satisfaction	0-3 (0: not satisfied...3: very satisfied)	1 week
Secondary	Patient's request for a similar technique next time	Yes/No	1 week