Does Pregabalin Improve Post-operative Pain After C-section Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Time to first analgesic request
研究概览
简要总结
Pregabalin due to its antihyperalgesic effect, has proven its efficacy on neuropathic pain, essentially in nociceptive surgeries. Few studies have attempted to identify the utility of pregabalin as a premedication before cesarean delivery.
The investigators aimed to determine whether or not pregabalin as premedication improves analgesia post cesarean delivery.
详细描述
The investigators conducted a controlled, randomised, prospective and double-blind trial. One hundred thirty eight participants were included, with American Society of Anesthesiologists physical status classification of I to II, with pregnancies of at least 36 weeks of gestation who were scheduled for elective caesarean delivery under spinal anaesthesia. One hour before induction of anaesthesia participants received a capsule containing sugar placebo (placebo group), pregabalin 150 mg or pregabalin 300 mg. Data related to surgical history, pre-existing medical problems, indications for cesarean and peroperative hemodynamic changes were analyzed. The primary outcome was first analgesic request. Secondary outcomes included maternal pain scores at rest and during movement, rescue analgesics consumption, sedation, nausea, vomiting, pruritus and Apgar scores. All maternal secondary outcome variables were recorded 0, 2, 4, 6, 12, 18, and 24 h after delivery. Common side effects linked to pregabalin such as somnolence, blurred or abnormal vision, or fetal distress were collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists class I or II
- •single pregnancies at term
- •under spinal anesthesia
排除标准
- •conversion to general anesthesia
- •post partum hemorrhage requiring specific resuscitation
- •local anesthetic toxicity
- •violation of the protocol
研究组 & 干预措施
Group C
two capsules filled with sugar
干预措施: Placebos (Drug)
Group P150
two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg)
干预措施: Pregabalin 150mg (Drug)
Group P300
two capsules of pregabalin (150 mg)
干预措施: Pregabalin 300mg (Drug)
结局指标
主要结局
Time to first analgesic request
时间窗: 24 hours
in minutes, the time between the end of the operation to the first demand of analgesics
次要结局
- Visual disturbances(24 hours post operatively)
- Visual analog scale (VAS) at rest and movement(24 hours)
- Maternal satisfaction(24 hours)
- Heart rate(Per operative period)
- Maternal consumption of paracetamol postoperatively(24 hours)
- Ramsay score for sedation(24 hours post operatively)
- Apgar scores(1 and 5 minutes after birth)
- Non-invasive blood pressure(Per operative period)
- Fluids administered to the mother per operatively(Per operative period)
- Dose of ephedrine administered to the mother per operatively(Per operative period)
研究者
Khemili Malek
Principal investigator
Hôpital Universitaire Fattouma Bourguiba