Clinical trial NCT04197752: Regional Anesthesia and Analgesia Techniques in Obese Patients
Official title: Use of Regional Anesthesia and Analgesia Techniques in Obese Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Regional Anesthesia
Keywords: Obesity
Neuroaxial blocks
Peripheral nerve blocks
Performance
Complication
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient eligible for regional anesthesia/analgesia procedures

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The difficulty of block performance
timeFrame: through the block performance, within 5-10 minutes
Secondary outcomes:
measure: The experience of the anesthesiologist
timeFrame: through the Anesthesiology residency training period, within 5 years and Anesthesiology experience, within 20 years
measure: The requirement of changing hands with a more experienced anesthesiologist
timeFrame: through the block performance, within 5-10 minutes
measure: The requirement of changing patient position
timeFrame: through the block performance, within 5-10 minutes
measure: The requirement of changing regional anesthesia/analgesia approach
timeFrame: through the block performance, within 5-10 minutes
measure: The requirement of changing needle size or length
timeFrame: through the block performance, within 5-10 minutes
measure: The requirement of adding rescue block
timeFrame: through the block performance, within 5-10 minutes
measure: Block performance duration
timeFrame: 0-30 minutes
measure: The number of needle direction
timeFrame: through the block performance, within 5-10 minutes
measure: The requirement of conversion to general anesthesia
timeFrame: through the block performance, within 5-10 minutes
measure: The requirement of adding another block monitorization technique
timeFrame: through the block performance, within 5-10 minutes
measure: Adverse effect/complication rate
timeFrame: 1 week
measure: Block success
timeFrame: 0-30 minutes
measure: Patient satisfaction
timeFrame: 1 week
measure: Patient's request for a similar technique next time
timeFrame: 1 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Emine A Salvız, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.