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临床试验/NCT04599842
NCT04599842已完成不适用

Analgesic Effect of Erector Spinae Plane Block After Caesarean Section: A Randomized Controlled Trial

Ataturk University2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2020年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
The primary outcome in this study was total opioid consumption for 24 hours.

研究概览

简要总结

Background: Our hypothesis was that bilateral ESP block applied from the transverse process of T9 in women who underwent elective cesarean section with pfannenstiel incision under spinal anesthesia could provide effective postoperative analgesia.The primary outcome in this study was total opioid consumption for 24 hours.

Material and Method: This randomized prospective study was carried out on 50 pregnant women who was scheduled for elective cesarean delivery via a Pfannenstiel incision with spinal anesthesia.Patients were randomly allocated in to two equal groups.Group SA was categorized as the group which spinal anaesthesia alone (SA) was performed, Group SA+ESP was categorized as group which SA+ESP block was performed. All groups received 7 mg isobaric bupivacaine +15 µg fentanyl intrathecally through spinal anesthesia. The SA+ESP group, ESP block was performed at the ninth thoracic transverse process with 20 ml 0.25% bupivacaine + 2 mg dexamethasone immediately after the operation. Total fentanyl consumption in 24 hrs, visual analogue scale (VAS) score for pain, time to the first analgesic request were evaluated postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women,38-42 gestational weeks, ASA I-II

排除标准

  • ≤18 or ≥45 age, has emergency obstetric surgery, pregnancy induced hypertension, significantly systematic disease, foetal or placental abnormality, hypersensitivity or allergy history to medicine to be used in the study, BMI≥35, autonomic neuropathy, diabetic, contraindicate to apply neuroachylic anaesthesia, who was transferred to general anaesthesia, could not decide or did not want to participate in the study, had severe respiratory and cardiac disease, was transferred to general anaesthesia, has infection, spine or chest wall deformity in operation area, has opioid dependence, chronic analgesic usage, inability to use a patient-controlled analgesia (PCA) device, couldn't be able to cooperative and express their pain with visual analogue scale score (VAS).

结局指标

主要结局

The primary outcome in this study was total opioid consumption for 24 hours.

时间窗: 24 hours

Total fentanyl consumption postoperative 24 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysenur Dostbil

MD

Ataturk University

研究点 (2)

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