ObesityNCT04197752
Regional Anesthesia and Analgesia Techniques in Obese Patients
An observational study of Obesity and Regional Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Regional Anesthesia
- What is being tested?
- Regional anesthesia/analgesia techniques
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient eligible for regional anesthesia/analgesia procedures
Who may be able to join
- Patients eligible for regional anesthesia/analgesia
- > 18 years old
- ASA 1-3
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University
Istanbul, 34093
Emine A Salvız, M.D., +905325225599, aysusalviz@gmail.com
Meltem M Guler, M.D., +905531863775, meltemmervek@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Regional Anesthesia
- Being tested
- Regional anesthesia/analgesia techniques
- Keywords
- Obesity, Neuroaxial blocks, Peripheral nerve blocks, Performance, Complication
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesia/analgesia techniquesOther
Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Body mass index > 30 kg/m2 Receives: Other: Regional anesthesia/analgesia techniques | |
| Non-obese patients | Body mass index < 30 kg/m2 Receives: Other: Regional anesthesia/analgesia techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difficulty of block performance
0: easy, 1: difficult, 2: very difficult
Measured: through the block performance, within 5-10 minutes
Secondary outcomes (14)
The experience of the anesthesiologist
0: Junior resident, 1: senior resident, 2: attending anesthesiologist, 3: assoc.prof./prof.anesthesiologist
Measured: 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
The number of changing
Measured: through the block performance, within 5-10 minutes
The requirement of changing patient position
Yes/No
Measured: through the block performance, within 5-10 minutes
The requirement of changing regional anesthesia/analgesia approach
Yes/No
Measured: through the block performance, within 5-10 minutes
The requirement of changing needle size or length
Yes/No
Measured: through the block performance, within 5-10 minutes
The requirement of adding rescue block
Yes/No
Measured: through the block performance, within 5-10 minutes
Block performance duration
Time period
Measured: 0-30 minutes
The number of needle direction
Number
Measured: through the block performance, within 5-10 minutes
The requirement of conversion to general anesthesia
Yes/No
Measured: through the block performance, within 5-10 minutes
The requirement of adding another block monitorization technique
Yes/No
Measured: through the block performance, within 5-10 minutes
Adverse effect/complication rate
Yes/No
Measured: 1 week
Block success
Yes/No
Measured: 0-30 minutes
Patient satisfaction
0-3 (0: not satisfied...3: very satisfied)
Measured: 1 week
Patient's request for a similar technique next time
Yes/No
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start20 May 2019
- Primary completion20 May 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Aysu Salviz, MD, Istanbul University
- Investigators
- Emine A Salvız, M.D., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197752
- Sponsor's protocol ID
- 2019/664
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16551933Hanouz 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.
PubMed 20418535
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Regional Anesthesia and Analgesia Techniques in Obese Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04197752
- Acronym / sponsor ID
- 2019/664
- Conditions
- Obesity, Regional Anesthesia
- Keywords
- Obesity, Neuroaxial blocks, Peripheral nerve blocks, Performance, Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Other: Regional anesthesia/analgesia techniquesBody mass index > 30 kg/m2 |
| Non-obese patients | – | Other: Regional anesthesia/analgesia techniquesBody mass index < 30 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient eligible for regional anesthesia/analgesia procedures
Key inclusion criteria (3 listed)
- Patients eligible for regional anesthesia/analgesia
- > 18 years old
- ASA 1-3
Key exclusion criteria (6 listed)
- < 18 years old
- Patient refusal for regional anesthesia/analgesia
- Patient refusal to participate in the study
- Allergic to local anesthetics
- Psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional anesthesia/analgesia techniquesNeuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery | Other | Non-obese patients, Obese patients |
Primary outcome
The difficulty of block performance
Time frame: through the block performance, within 5-10 minutes
0: easy, 1: difficult, 2: very difficult
14 secondary outcomes
The experience of the anesthesiologist
Time frame: 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
Time frame: through the block performance, within 5-10 minutes
The requirement of changing patient position
Time frame: through the block performance, within 5-10 minutes
The requirement of changing regional anesthesia/analgesia approach
Time frame: through the block performance, within 5-10 minutes
The requirement of changing needle size or length
Time frame: through the block performance, within 5-10 minutes
The requirement of adding rescue block
Time frame: through the block performance, within 5-10 minutes
Block performance duration
Time frame: 0-30 minutes
The number of needle direction
Time frame: through the block performance, within 5-10 minutes
The requirement of conversion to general anesthesia
Time frame: through the block performance, within 5-10 minutes
The requirement of adding another block monitorization technique
Time frame: through the block performance, within 5-10 minutes
Adverse effect/complication rate
Time frame: 1 week
Block success
Time frame: 0-30 minutes
Patient satisfaction
Time frame: 1 week
Patient's request for a similar technique next time
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Background: PubMed 16551933Franco 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.
- Background: PubMed 20418535Hanouz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine A Salvız, M.D. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Regional Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emine A Salvız, M.D. (+905325225599, aysusalviz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difficulty of block performance (time frame: through the block performance, within 5-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197752, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.