- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07638280
Non-Pharmacological Factors on Spinal Block Duration
Analysis of Non-pharmacological Factors on Spinal Anaesthesia Block Duration
연구 개요
상세 설명
It is well known that the level of sensory and motor block following spinal anesthesia varies among individuals. This variability is not only related to the dose of local anesthetic but has also been reported to be associated with patient-related non-pharmacological factors. In particular, a relationship has been demonstrated between body mass index (BMI) and both the level and duration of spinal block, with higher block levels and prolonged block duration observed in patients with increased BMI. This phenomenon is thought to be associated with epidural venous distension due to increased intra-abdominal pressure and a reduction in subarachnoid cerebrospinal fluid (CSF) volume. A decrease in CSF volume may facilitate greater cephalad spread of intrathecal local anesthetic agents, thereby prolonging block duration.
Paraspinal muscle mass is also an important anatomical parameter that may influence intra-abdominal pressure and epidural space compliance, and thus may play a determining role in the spread of spinal anesthesia. However, although several studies have investigated the relationship between BMI and body composition and spinal block characteristics, the number of clinical studies directly evaluating the association between ultrasonographically measured paraspinal muscle mass and spinal anesthesia block duration remains limited. Therefore, ultrasonographic measurement of paraspinal muscle thickness may serve as a potential predictor of spinal block duration.
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients aged 18-80 years
- ASA physical status I-III
- Patients scheduled for elective lower abdominal surgery.
Exclusion Criteria:
- Patient refusal to participate
- Coagulopathy
- Use of medications or substances known to impair coagulation
- Pregnancy, sepsis
- Shock
- Severe aortic or mitral regurgitation
- Peripheral vascular disease
- Increased intracranial pressure
- Mental disorders
- Spinal column deformity
- History of previous spinal surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Paraspinal mass measurement with ultrasound.
기간: Pre-operative
|
Ultrasonographic measurement of paraspinal muscle thickness (cm) and its association with duration of spinal block will be investigated.
|
Pre-operative
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The spread of the spinal block
기간: Perioperative/Periprocedural
|
The speed of the sensational block will be measured after spinal anaesthesia performed. Time(minute) will be recorded when T10 level sensational block is achieved. |
Perioperative/Periprocedural
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Kahveci M, Ugur L. The Effect of Injection Parameters on Drug Distribution for Spinal Anesthesia: A Numerical Approach. J Clin Med. 2025 Sep 3;14(17):6236. doi: 10.3390/jcm14176236.
- Paliwal N, Khan IA. Exploring Variability in Spinal Anesthesia Levels Achieved During Cesarean Section Deliveries: A Narrative Review. Cureus. 2025 Jul 21;17(7):e88429. doi: 10.7759/cureus.88429. eCollection 2025 Jul.
- Belavy DL, Armbrecht G, Felsenberg D. Real-time ultrasound measures of lumbar erector spinae and multifidus: reliability and comparison to magnetic resonance imaging. Physiol Meas. 2015 Nov;36(11):2285-99. doi: 10.1088/0967-3334/36/11/2285. Epub 2015 Oct 9.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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. .
spinal anaesthesia에 대한 임상 시험
-
Ataturk Training and Research Hospital완전한
-
Bursa Yuksek Ihtisas Training and Research Hospital완전한
-
Gazi University완전한약물 효과 | 마취 | 일반 외과 | 외래환자 | 항문직장 장애