- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04197752
Regional Anesthesia and Analgesia Techniques in Obese Patients
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Istanbul, 칠면조, 34093
- 모병
- Istanbul University
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연락하다:
- Emine A Salvız, M.D.
- 전화번호: +905325225599
- 이메일: aysusalviz@gmail.com
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연락하다:
- Meltem M Guler, M.D.
- 전화번호: +905531863775
- 이메일: meltemmervek@gmail.com
-
수석 연구원:
- Meltem M Guler, M.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 크로스오버
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Obese patients
Body mass index > 30 kg/m2
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Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery
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Non-obese patients
Body mass index < 30 kg/m2
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Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The difficulty of block performance
기간: through the block performance, within 5-10 minutes
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0: easy, 1: difficult, 2: very difficult
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through the block performance, within 5-10 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The experience of the anesthesiologist
기간: through the Anesthesiology residency training period, within 5 years and Anesthesiology experience, within 20 years
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0: Junior resident, 1: senior resident, 2: attending anesthesiologist, 3: assoc.prof./prof.anesthesiologist
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through the Anesthesiology residency training period, within 5 years and Anesthesiology experience, within 20 years
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The requirement of changing hands with a more experienced anesthesiologist
기간: through the block performance, within 5-10 minutes
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The number of changing
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through the block performance, within 5-10 minutes
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The requirement of changing patient position
기간: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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The requirement of changing regional anesthesia/analgesia approach
기간: through the block performance, within 5-10 minutes
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Yes/No
|
through the block performance, within 5-10 minutes
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The requirement of changing needle size or length
기간: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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The requirement of adding rescue block
기간: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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Block performance duration
기간: 0-30 minutes
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Time period
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0-30 minutes
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The number of needle direction
기간: through the block performance, within 5-10 minutes
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Number
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through the block performance, within 5-10 minutes
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The requirement of conversion to general anesthesia
기간: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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The requirement of adding another block monitorization technique
기간: through the block performance, within 5-10 minutes
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Yes/No
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through the block performance, within 5-10 minutes
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Adverse effect/complication rate
기간: 1 week
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Yes/No
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1 week
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Block success
기간: 0-30 minutes
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Yes/No
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0-30 minutes
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Patient satisfaction
기간: 1 week
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0-3 (0: not satisfied...3: very satisfied)
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1 week
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Patient's request for a similar technique next time
기간: 1 week
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Yes/No
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1 week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Emine A Salvız, M.D., Istanbul University
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .