Effect of Epidural Dexmedetomidine VS Nalbuphine for Labor Analgesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- change in VAS score for pain before analgesia and every 30 minutes after analgesia
研究概览
简要总结
The aim of this study is to compare epidural dexmedetomidine vs nalbuphine added to bupivacaine in labor analgesia and determine the privilege of one over the other and to compare the effect of both analgesics after delivery.
详细描述
Labor pain often causes a strong stress response in women. Recently, it is concerned by most mothers and doctors that how to effectively alleviate the pain during delivery. There is no standard treatment for labor pain. A wide range of pharmacological and non-pharmacological labor pain relief techniques are available for pregnant women . Labor analgesia, also known as painless childbirth, refers to the use of various methods to reduce maternal labor pain or make it disappear. The ideal labor analgesia should be based on maternal and child safety, and should have fast acting, good analgesic effect and less adverse reaction. Epidural block anesthesia is convenient, and has less adverse reaction and obvious effect in the commonly used analgesic methods, which is widely used in the current way of analgesia. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that has sedative, hypnotic, and analgesic effects . Nalbuphine is a synthetic agonist antagoLabor pain often causes a strong stress response in women. Recently, it is concerned by most mothers and doctors that how to effectively alleviate the pain during delivery. There is no standard treatment for labor pain. A wide range of pharmacological and non-pharmacological labor pain relief techniques are available for pregnant women . Labor analgesia, also known as painless childbirth, refers to the use of various methods to reduce maternal labor pain or make it disappear. The ideal labor analgesia should be based on maternal and child safety, and should have fast acting, good analgesic effect and less adverse reaction. Epidural block anesthesia is convenient, and has less adverse reaction and obvious effect in the commonly used analgesic methods, which is widely used in the current way of analgesia. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that has sedative, hypnotic, and analgesic effects . Nalbuphine is a synthetic agonist antagonist opioid that has the characteristics of mu-antagonist and kappa-agonist activities. Nalbuphine has gained popularity as a parenteral analgesic for intraoperative, postoperative, and obstetrical uses . The purpose of this study is to compare between the 2 drugs in decreasing labor pain. st opioid that has the characteristics of mu-antagonist and kappa-agonist activities. Nalbuphine has gained popularity as a parenteral analgesic for intraoperative, postoperative, and obstetrical uses . The purpose of this study is to compare between the 2 drugs in decreasing labor pain.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All the parturients should :
- •Be between 21 - 40 years old
- •ASA classification I- II
- •Requesting analgesia
- •Have a normal birth canal
- •Be at the beginning of active phase of labor i.e. cervical dilatation of 4 cm with regular uterine contractions.
- •The fetus should be a single full-term fetus (37- 42 weeks of gestation) with normal head position, normal development.
排除标准
- •Parturients
- •Younger than 21 and older than 40 years old
- •With contraindication of regional anesthesia
- •With pre-existing neurological disease
- •With history of allergy to the study drugs
- •With cephalopelvic disproportion, fetal distress, amniotic fluid infection, placental insufficiency or scarred uterus
研究组 & 干预措施
Group A (Dexmedetomidine group)
a bolus dose of 11ml of 0.25% bupivacaine + 0.5μg/ml preservative free dexmedetomidine (1ml volume) will be injected via the epidural catheter. For top up 5 ml of 0.25% bupivacaine + 0.5μg/ml dexmedetomidine (1ml volume) will be given when VAS score becomes 4 or more.
干预措施: Dexmedetomidine (Drug)
Group B (Nalbuphine group)
a bolus dose of 11ml of 0.25% bupivacaine + 10mg preservative free nalbuphine (1ml volume) will be injected via the epidural catheter. For top up 5 ml of 0.25% bupivacaine + 2mg nalbuphine (1ml volume) will be given when VAS score becomes 4 or more.
干预措施: Nalbuphine (Drug)
结局指标
主要结局
change in VAS score for pain before analgesia and every 30 minutes after analgesia
时间窗: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)
The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a 100 mm (10 cm) horizontal line, and this rating is then measured from the left edge (=VAS score). The VAS score correlates well with acute pain levels (Myles et al., 1999). Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the no pain anchor and the patients mark, providing a range of scores from 010. A higher score indicates greater pain intensity.
次要结局
- change in SpO2 before analgesia and every 30 minutes after analgesia(before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes))
- Duration of active phase of 1st stage of labor(from 100 minutes to 300 minutes)
- change in Heart rate before analgesia and every 30 minutes after analgesia(before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes))
- change in arterial blood pressure before analgesia and every 30 minutes after analgesia(before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes))
- Duration of 2nd stage of labor(from 30 minutes to 200 minutes)
- Duration of 3rd stage of labor(from 5 minutes to 15 minutes)
- Neonatal condition: APGAR score at 1 and 5 min after the birth(At 1 minute and 5 minutes after birth)
- The adverse reactions: itching, nausea, vomiting, bradycardia and hypotension(As long as the epidural catheter is inserted (up to 360 minutes))
研究者
Nourhan Tarek
Principal Investigator
Ain Shams University