A Prospective Randomized Double-blind, Placebo-controlled Study of the Effect of Preoperative Analgesia With Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.
试验速览
- 阶段
- 不适用
- 试验地点
- 1
研究概览
简要总结
The objective of this prospective, double-blinded, placebo-controlled, randomized study is to evaluate the impact of preemptive analgesia using incisional site infiltration of lidocaine as compared to saline solution on post operative pain control in women undergoing cesarean deliveries.
详细描述
The studied population would be based on women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.
Prior to each operation, the surgeon will be provided with a syringe containing a 20 mL solution of 1% lidocaine or 0.9% sodium chloride, which will be injected subcutaneously to the incisional site region after anesthesia and before the beginning of the surgery.
After the operation the conventional post cesarean analgesic regime will be used and recorded for all women.
The self-report of pain will be assessed by the patient using a validated visual analog scale, as instructed by the nursing staff.
The patient's mark will be used as a numerical index of pain intensity. The reports will be taken by the patients in intervals of 4 hours for 48 hours after the operation. In addition, analgesic requirements of the patient will be monitored and recorded by the nursing staff and used for comparison between the two study group
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.
排除标准
- •More than two previous cesarean deliveries
- •Other abdominal operations in the past
- •Morbid obesity
- •Diabetes mellitus, neurological diseases, systemic vascular disease.
- •Mental disability
- •Lidocaine sensitivity
研究组 & 干预措施
B
干预措施: lidocaine (Drug)
A
干预措施: NACL 0.9% (Drug)