Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pain Assessment
研究概览
简要总结
The goal of this study is to evaluate the quality and safety of labor analgesia by comparing the use of Dural puncture epidural technique to Standard epidural technique while maintaining labor analgesia by means of continuous epidural infusion in parturient. The main questions it aims to answer are
- Effectiveness and quality of labor analgesia
- Frequency of catheter adjustments
- Need for catheter replacements
- Incidence of failed regional anesthesia requiring conversion to general anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous / Multiparous women
- •Age >18 years
- •ASA 1 & 2
- •Singleton vertex presentation
- •Gestational age 37-42 weeks
- •Parturient with established labor and pain score ≥ 3
排除标准
- •Major cardiac disease
- •History of chronic pain
- •Chronic opioid user
- •Platelet count < 70 x 109/L
- •spinal cord anomalies
- •Use of anticoagulants
- •Allergic to local anesthetics
- •Patients with preeclampsia/ eclampsia
- •Known fetal anomalies
结局指标
主要结局
Pain Assessment
时间窗: At 30 minutes of initiation of infusion
Pain assessment by using numerical rating pain score and assessing sensory level. Numerical rating score: Pain Assessment: Numerical rating scale (NRS) 0 to 10. 0=no pain, 1-3 =mild pain, 4-7 =Moderate pain, 8-10= severe pain. Assessing sensory level: Testing will be done on specific dermatomes and will be compared bilaterally by either using one of these tests. 1. Light Touch Test: Dab a piece of cotton wool on an area of skin. 2. Temperature test: by using Ice on specific dermatomes and ask the patient if they feel cold sensation 3. Pinprick Test for pain sensation - Gently touch the skin with the pin ask the patient whether it feels sharp or blunt.
Need for catheter adjustment
时间窗: At 30 minutes of initiation of infusion
Persistence of either unilateral pain score (NRS) of \>4, thirty minutes after 2 boluses of 10ml of 0.125% Bupivacaine
次要结局
- Patient Satisfaction(At 30 minutes of initiation of infusion)
- Assessment of the level of motor Block(At 30 minutes after the initiation of infusion)
研究者
Samina Ismail
Professor
Aga Khan University