Effect of Intraperitoneal Gas Drain on Postoperative Pain After Gynecologic Laparoscopy: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 主要终点
- Severity of postoperative shoulder pain using the Visual Analog Scale (VAS)
研究概览
简要总结
This randomized controlled trial aims to evaluate whether the use of an intraperitoneal gas drain at the end of gynecologic laparoscopic surgery can reduce postoperative shoulder pain. Residual carbon dioxide after laparoscopy is believed to irritate the diaphragm and cause referred shoulder pain, which is a common and distressing postoperative symptom. Women undergoing gynecologic laparoscopy lasting more than 20 minutes will be randomized to receive either an intraperitoneal drain for passive gas evacuation or standard care without a drain. Shoulder pain, abdominal pain, analgesic consumption, postoperative nausea and vomiting, and recovery indicators will be assessed during the first 48 hours after surgery.
详细描述
Post-laparoscopic shoulder pain is a frequent complaint after gynecologic laparoscopy and is mainly attributed to residual carbon dioxide retained in the peritoneal cavity, which irritates the diaphragm and stimulates the phrenic nerve. This study is designed to investigate a simple mechanical intervention-placement of an intraperitoneal gas drain-to facilitate passive evacuation of carbon dioxide and potentially reduce postoperative pain.
Women undergoing gynecologic laparoscopy lasting more than 20 minutes at the Department of Obstetrics and Gynecology, Women's Health University Hospital, Assiut University, will be recruited and randomized into two equal groups. The intervention group will receive a plastic intraperitoneal drain placed through the umbilical port and left in situ for 24 hours postoperatively. The control group will undergo standard gas evacuation without drain placement.
Pain will be assessed using a 10-cm Visual Analog Scale (VAS) at recovery, 6, 12, 24, and 48 hours postoperatively for both shoulder and abdominal pain. Secondary outcomes include total analgesic consumption within 48 hours, incidence of postoperative nausea and vomiting, time to return of intestinal sounds, and time to first mobilization. The primary outcome is the mean shoulder pain score at 24 hours.
This trial aims to provide high-quality evidence on the effectiveness of intraperitoneal gas drainage in reducing postoperative discomfort following gynecologic laparoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing gynecologic laparoscopy lasting more than 20 minutes.
- •Able and willing to provide informed consent.
排除标准
- •Refusal to participate.
- •Patients unable to give consent or unable to participate in pain assessment.
结局指标
主要结局
Severity of postoperative shoulder pain using the Visual Analog Scale (VAS)
时间窗: At 24 hours after surgery
Shoulder pain severity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
次要结局
- Postoperative shoulder pain (VAS) at 48 hours(At 48 hours after surgery)
- Postoperative shoulder pain (VAS) at 6 hours(At 6 hours after surgery)
- Postoperative shoulder pain (VAS) at 12 hours(At 12 hours after surgery)
- Total analgesic consumption within 48 hours(Up to 48 hours after surgery)
- Postoperative shoulder pain (VAS) at 24 hours(At 24 hours after surgery)
- Time to first mobilization(Up to 48 hours after surgery)
- Incidence of postoperative nausea and vomiting(Up to 48 hours after surgery)
- Time to return of bowel sounds(Up to 48 hours after surgery)
研究者
Mohamed Shehata Mohamed
Doctor
Assiut University