A Randomized, Controlled, Single Blind Study Comparing a Pulmonary Recruitment Maneuver Versus Intraperitoneal Infusion of Normal Saline to Reduce Shoulder Tip Pain After Gynecologic Laparoscopic Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- the severity and frequency of shoulder-tip pain after laparoscopic surgery
研究概览
简要总结
Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.
The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to reduce carbon dioxide retention in the pelvic cavity.
详细描述
This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients receive benign gynaecological laparoscopic surgery.
- •American Society of Anesthesiologists (ASA) physical status of patient:
- •classification I-II
排除标准
- •The procedure will be required to conversion to laparotomy.
- •Any cardio-vascular diseases.
结局指标
主要结局
the severity and frequency of shoulder-tip pain after laparoscopic surgery
时间窗: the first 48 hours after the surgery
We will follow the patients in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder-tip pain after laparoscopic surgery. The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder-tip pain after laparoscopic surgery.
次要结局
- Nausea or abdominal fullness after laparoscopic surgery(the first 48 hours after the surgery)