The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
研究概览
简要总结
The purpose of this study is to determine whether a single dose of gabapentin, given before cesarean section, will reduce pain in the initial 24 hours after surgery. Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of surgeries. We believe that it may be effective for treating pain after cesarean sections, but it has never been studied for this purpose.
详细描述
A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive a single dose of a gabapentin before the surgery. We are also interested in whether or not the dose of gabapentin reduces the need for other pain-killing medication during this time.
Patients will be randomly assigned to receive either gabapentin or a placebo. In addition, all patients will receive the usual standard of care and medication for pain (intrathecal morphine,oral paracetamol and diclofenac). At 4, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The dose of gabapentin given is thought to be safe for the baby, and we plan to investigate whether the gabapentin has any effect on the baby's pain response when given his/her vitamin K injection. Gabapentin has also been shown to reduce long-term pain that can develop, and patients will be followed up at 6 weeks to be asked about their pain at that time.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing elective cesarean delivery
排除标准
- •Patients unable to communicate in English
- •Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
- •Patients with contraindications to any of the medications used in the study
- •Patients with contraindications to spinal anesthesia
- •Patients who have taken any pain medication in the past week
- •Patients with fetuses having congenital abnormalities
- •Patients with severe mental disorders
- •Patients with HIV or hepatitis infections
- •Intravenous drug users
- •Patients with uncontrolled hypertension and diabetes
- •Patients with central nervous system tumours
研究组 & 干预措施
1
Gabapentin
干预措施: Gabapentin (Drug)
2
Placebo
干预措施: lactose (Other)
结局指标
主要结局
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
时间窗: 24 hours
次要结局
- Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively.(48)
- Opioid consumption at 4, 12, 24 & 48 hours postoperatively.(48)
- Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required.(48 hours)
- Time to first maternal request for supplemental analgesia.(48 hours)
- Presence of pain 3 months postoperatively.(3 months)
- Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission(48 hours)
- Neonatal pain response at vitamin K injection (0-100%)(1 hour)
- Maternal gabapentin levels (25 patients)(6 months (samples will be stored and sent together))