The Effect of Changing the Programmed Auto Bolus Interval Time On Analgesic Quality of Labor Analgesia With Dural Puncture Epidural Technique: Double-Blind Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Difference between total local anaesthetic consumption
研究概览
简要总结
It is aimed in this study to compare the effect of changing the interval time for programmed auto boluses of local anaesthetics on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.
详细描述
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy nulliparous women
- •American Society of Anaesthesiology Score of II
- •During active labor
- •At weeks 37-
- •Singlet vertex presentation
- •Cervical dilation <5 cm at the request of labor analgesia
- •VAS score >40
排除标准
- •Age <20 or >45,
- •Morbid obesity
- •Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia)
- •History of drug abuse
- •Contrindication for neuraxial blocks
- •Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries)
- •Diagnosed fetal abnormalities
- •Cases where dura gets punctured unintendedly with the epiduralneedle
- •Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture
- •Cases where a cesarean section is performed at any stage of labor
- •Cases where labor is completed in 1 hour from the start of analgesia procedure.
- •Exclusion Criteria:
结局指标
主要结局
Difference between total local anaesthetic consumption
时间窗: 5 hours or before if the labor is completed
The study will involve monitoring the patients starting 2 minutes after the initial epidural dose, every 2 minutes during the first 20 minutes. Monitoring will continue at the 30th minute, and once in every 90 minutes for 5 hours or until labor is completed. Total bupivacain consumption will be calculated as follows: PIEB + PCEA + boluses by the clinician. Bupivacain consumption per hour will be calculated.
次要结局
未报告次要终点
研究者
Aysenur Dostbil
Clinical Professor
Ataturk University