Postoperative Pain Control Using Continuous Infusion of Levobupivacaine in Women Undergoing Pelvic Operative Laparoscopy: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rescue analgesia use
研究概览
简要总结
This study is a blinded randomised study of slow release levobupivacaine vs saline for women undergoing day case operative pelvic laparoscopy. Participants will be randomly given either saline or levobupivacaine and efficacy will be measured using ranked ordinal pain scales and rescue oral analgesia use.
详细描述
METHOD:
This is a triple-blinded randomised control study to determine whether a continuous intraperitoneal infusion of levobupivacaine 0.5%, when compared with normal saline 0.9%, in women undergoing laparoscopic pelvic surgery as day-case, provides effective postoperative analgesia.
Primary outcome measure:
• Need for 'rescue' analgesia
Secondary outcome measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing 'Day case' operative laparoscopic procedures.
- •These women are deemed suitable to return home on the day of surgery, both in terms of physical fitness and their home circumstances.
排除标准
- •Women having laparoscopic procedures for diagnostic purposes or minor operations such as sterilisation, will be excluded from the study.
- •These procedures are less likely to cause significant pain due to operation.
研究组 & 干预措施
Saline
Placebo solution
干预措施: levobupivacaine (Drug)
levobupivacaine, analgesia
Active drug
干预措施: levobupivacaine (Drug)
结局指标
主要结局
Rescue analgesia use
时间窗: 48 hours
participants will record number of doses of oral analgesic tablets they required.
次要结局
- Pain intensity on movement and rest(48 hours)