Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there is no evidence of this benefit. The objective of this study is to verify the degree of pain after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the portal, or placebo
详细描述
In order to conduct this study, the internal and external validation were considered.
The author will use different gynecological teams, with different expertise to perform the laparoscopic tubal ligation, but using the same surgical and anesthesic technique. Second year residents, during their rotation, and medical staff will perform the surgery.
Anesthesic technique:
Intravenous remifentanil 0.1-0.5 micrograms/kg/min Intravenous Propofol target controlled or sevoflurane Intermittent ventilation using O2 40 - 100%, with or without compressed air. Before incision: 5mL of bupivacaine 0.5% or saline solution 0.9% from the aponeurosis until the skin In the end of the procedure: intravenous 4mg of dexamethasone + 40mg of tenoxican
Post-operation prescription:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients schedule for laparoscopic tubal ligation
排除标准
- •Not willing to consent
- •Use of analgesic within 12 hours prior the surgery
- •Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac
研究组 & 干预措施
1
Saline solution 0.9% 5mL in each portal
干预措施: Saline solution (laparoscopic tubal ligation) (Drug)
2
Bupivacaine 0.5% 5mL in each portal
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Pain
时间窗: at 15, 30 and 120 minutes and 14 hours after surgery
次要结局
- Use of medication for pain(at 15, 30 and 120 minutes after surgery and 14 hours later)