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临床试验/NCT06653036
NCT06653036
招募中
不适用

Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial

Aga Khan University1 个研究点 分布在 1 个国家目标入组 38 人2024年11月28日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Quality Health Care
发起方
Aga Khan University
入组人数
38
试验地点
1
主要终点
Pain Assessment
状态
招募中
最后更新
去年

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
注册库
clinicaltrials.gov
开始日期
2024年11月28日
结束日期
2025年12月31日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Samina Ismail

Professor

Aga Khan University

入排标准

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)

研究点 (1)

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