Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour: A Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Success of epidural catheterization on the first attempt.
研究概览
简要总结
Epidural analgesia is the gold standard for painless labour, but successful catheter placement can be technically challenging due to anatomical and physiological changes in pregnancy. Injecting saline or local anesthetic through the epidural needle before catheter insertion has been proposed to facilitate catheter advancement by dilating the epidural space. This study aimed to evaluate the effect of epidural needle injection on the success rate and ease of catheter placement during labour analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-40 years.
- •ASA physical status II or III.
- •Singleton pregnancy.
- •Gestational age ≥37 weeks.
- •Active labour with cervical dilatation ≥3 cm.
- •Cephalic presentation.
- •Requesting epidural analgesia for painless labour.
- •Ability to provide written informed consent.
排除标准
- •• Refusal to participate or to sign informed consent.
- •Age <18 or >40 years.
- •ASA status ≥IV.
- •Allergy to local anesthetics or saline.
- •Coagulopathy or platelet count <100,000/mm³.
- •Local infection at the insertion site.
- •Severe spinal deformity (scoliosis, kyphosis).
- •Multiple pregnancy.
- •Non-cephalic presentation (breech, transverse).
- •Antepartum hemorrhage or placenta previa.
- •Severe preeclampsia or eclampsia.
- •Signs of fetal distress.
- •Previous lumbar spine surgery.
- •Difficult epidural anatomy (on ultrasound or palpation).
- •BMI >40 kg/m²
结局指标
主要结局
Success of epidural catheterization on the first attempt.
时间窗: Assessed immediately during the procedure at the time of epidural catheter placement.
The incidence of success of epidural catheterization on the first attempt will be determined. This measures whether the epidural catheter is successfully inserted on the first attempt after loss of resistance, without the need for repositioning or reattempt. Success is defined by obtaining adequate analgesia with proper catheter function (confirmed by clinical effect).
次要结局
- Number of catheterization attempts(Assessed during the procedure until successful catheterization is achieved.)
- Procedure duration(Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.)
- Incidence of numbness(Assessed post-catheter insertion, within the first 30 minutes after drug administration.)
- Number of catheterization attempts(Assessed during the procedure until successful catheterization is achieved.)
- Procedure duration(Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.)
- Incidence of numbness(Assessed post-catheter insertion, within the first 30 minutes after drug administration.)
- Incidence of unintended dural puncture(Assessed immediately at the time of needle insertion or catheter placement.)
- Maternal satisfaction(Assessed post-delivery, usually within 24 hours after labour.)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University