Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Duration of pain relief
研究概览
简要总结
Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery
详细描述
Labor is a physiological and natural process, as well as a complicated and subjective experience.Except for a few women, childbirth is unquestionably a painful experience. Women's understanding of delivery's pain is influenced by various factors, making each experience special. As opposed to other painful life events, labor pain consistently ranks high on the pain rating scale.
In this study ,the investigators are going to investigate the effectiveness and safety of intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine.
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)
盲法说明
Computer generated number lists and use of sealed opaque envelopes , double blinded trial
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dexmedetomidine Group
participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 5μg dexmedetomidine(0.05ml dexmedetomidine in insulin syringe+ 0.95ml normal saline).
干预措施: Dexmedetomidine (Drug)
Fentanyl group
participants will receive intrathecal injection of 5 mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 12.5μg fentanyl(0.25ml fentanyl in insulin syringe+ 0.75ml normal saline).
干预措施: Fentanyl (Drug)
Control group
participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline
干预措施: Bupivacaine Hcl 0.5% Inj (Drug)
结局指标
主要结局
Duration of pain relief
时间窗: Up to 6 hours after intrathecal injection
The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4
maximum level of sensory block
时间窗: 15 min after the intrathecal injection
Temperature will be assessed using methylated soaked swabs on both sides of the body
visual analogue scale (VAS) of the labour pain
时间窗: 6 hours after intrathecal injection
The VAS (ranging from 0 = pain-free up to 10 = worst imaginable pain) of the labour pain will be recorded before the intrathecal injection, every 5 min for the first 20 min, then every 30 min for 6 hours
S1 regression time
时间窗: 6 hours after intrathecal injection
S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome
analgesic onset time
时间窗: within 15 minutes after intrathecal injection
The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4
次要结局
- Maternal heart rate(6 hours post operative)
- Maternal blood pressure(6 hours post operative)
- Fetal APGAR score(till 5 minutes after delivery)
- Post operative nausea and vomiting(6 hours post operative)
- Post operative urinary retention(6 hours post operative)
- Fetal heart sounds(from intrathecal injection till delivery)