The Influence of Combining the Pulmonary Recruitment Maneuver with Active Gas Aspiration on Post-laparoscopic Shoulder Pain in Patients Having a Gynecologic Laparoscopy, Randomized Double Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- post-laparoscopic shoulder pain by VAS score
研究概览
简要总结
Laparoscopy is among the most used minimally invasive procedures that can reduce postoperative pain, lessen the duration of hospital stay and facilitate recovery. Laparoscopy has been widely used in various abdominal surgeries, such as gastrectomy, cholecystectomy, appendectomy, hernia and gynecological surgery . However, the post-laparoscopic shoulder pain (PLSP) often occurs following laparoscopic surgeries, and its reported incidence varies from 35-80% This study aims to assess the effect of combining pulmonary recruitment maneuvers (PRM) with active gas aspiration on post-laparoscopic shoulder pain in patients undergoing gynecological laparoscopic procedures.
详细描述
The PLSP can even remain for up to three days and often upsets the patients . Moreover, it can increase the costs of healthcare owing to an increased usage of analgesics, delayed discharge, and even re-admission .
Therefore, necessary measures should be taken to diminish the intensity of PLSP. Although the exact mechanism of PLSP remains unclear, some studies have suggested that it is caused by the trapping of carbon dioxide (CO2) between the liver and the right diaphragm and subsequent conversion into carbonic acid, which irritates the diaphragm and subsequently generates referred shoulder pain (C4 dermatomal) . Therefore, several studies have attempted to decrease the incidence or severity of PLSP by promoting the removal of remaining CO2 from the abdominal cavity. These efforts include drainage tube insertion, intraperitoneal saline instillation (IPSI), and the usage of intraperitoneal local anesthetic agents . More-over, the pulmonary recruitment maneuver (PRM) can also facilitate the removal of CO2 from the abdominal cavity by increasing positive airway pressure and intrathoracic pressure. PRM is more commonly used in clinical practice because it does not require drugs, specialized apparatus, or additional medical costs, unlike the other methods . Several trials have described the advantages of PRM in patients undergoing laparoscopic operations compared to passive abdominal compression.
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 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Age 18- 65 years.
- •American Society of Anesthesiologists physical status classification (ASA) I - II
- •scheduled for an elective gyncologic laparoscopic procedures
排除标准
- •• Urgent or emergency case.
- •ASA classification more than III.
- •Age less than 16 years.
- •Reduced left and right ventricular function (ejection fraction <40%).
- •Previous respiratory disease such as chronic obstructive pulmonary disease, restrictive lung disease, or had a history of thoracic or shoulder surgery
- •Patient conversion to a laparotomy.
- •the operation time is more than 3 h
研究组 & 干预措施
group 1
The surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas
干预措施: active gas aspiration (Procedure)
group 2
The surgeon will be instructed to apply PRM pressures. patients will receive the PRM which consisted of five manual pulmonary inflations,
干预措施: pulmonary recruitment maneuver (Procedure)
结局指标
主要结局
post-laparoscopic shoulder pain by VAS score
时间窗: 24 hours
post-laparoscopic shoulder pain by VAS score
次要结局
未报告次要终点
研究者
Mahmoud Essam Salama Hammam
resident doctor at Assiut University hospital
Assiut University
