Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Duration of maternal analgesia
研究概览
简要总结
Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics.
The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 41 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status class II and III,
- •Full term pregnancy.
排除标准
- •Patient refusal to epidural analgesia,
- •Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),
- •Cardiac diseases
- •Severe pre-eclampsia,
- •Breech presentations
- •Antepartum hemorrhage
- •Cephalopelvic disproportion
- •Body mass index ≥40 kg/m2.
研究组 & 干预措施
Group D (Dexmedetomidine group)
Epidural analgesia with levobupivacaine and dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Group C (Control group)
pidural analgesia with levobupivacaine alone
干预措施: levobupivacaine (Drug)
Group D (Dexmedetomidine group)
Epidural analgesia with levobupivacaine and dexmedetomidine
干预措施: levobupivacaine (Drug)
Group F (Fentanyl group)
Epidural analgesia with levobupivacaine and fentanyl
干预措施: levobupivacaine (Drug)
Group F (Fentanyl group)
Epidural analgesia with levobupivacaine and fentanyl
干预措施: Fentanyl (Drug)
结局指标
主要结局
Duration of maternal analgesia
时间窗: 24 hours after epidural injection
Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be ≥ 4. The pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, \> 7: severe pain).
次要结局
- Onset of maternal analgesia.(One hour after epidural injection)
- Complications of drugs of epidural technique(24 hours after epidural injection)
研究者
Hend Mahmoud Moneeb El-shazly
Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University