Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Shoulder pain (12 hours)
研究概览
简要总结
Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative shoulder pain. Shoulder pain post laparoscopy is common and it is a major cause of patient dissatisfaction. The aim of our study is to evaluate the efficacy of positioning the patient in Trendelenburg, post operatively for 24 hours, on shoulder pain reduction. Our hypothesis is based on the assumption that complete CO2 deflation is not possible and that Trendelenburg positioning will help displace CO2 from the sub diaphragmatic area thus reducing the diaphragmatic and phrenic nerve irritation causing pain.
详细描述
A prospective randomized controlled study with 54 patients in each of the two arms. Group S (control) will undergo the standard laparoscopic procedure and the patients will be placed in supine head up position postoperatively. In group T (interventional); the patients will be positioned in Trendelenburg position once fully awake and cooperative in the post-anesthesia case unit (PACU) and will remain in this position for the first 24 hours postoperatively. Postoperative NRS(numeric rating scale) score for shoulder pain and nausea will be collected at arrival to PACU, & 4, 6, 12 and 24 hours postoperatively. In addition, total amount of rescue pain and nausea medication used by the patient will be recorded. Data collected will be analyzed and compared between the two groups. The independent t- test will be used to compare postoperative shoulder pain, with NRS scores treated as continuous variable, between the two groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Age: 18 years to 60 years, American Society of Anesthesiologist physical status (ASA) 1 or 2
- •Diagnostic or operative gynecologic laparoscopy {4 port sites, three 5 mm trocars (suprapubic, right and left iliac fossa) and one 10 mm trocar (umbilical)} between one and 3 hours duration.
- •Abdominal incisions less than 1.5 cm.
- •Steady abdominal insufflation pressure of 14 mm Hg following a gradual insufflation over a 5-minute period.
- •Insufflation at a steady maximal flow of 30 l/min
排除标准
- •Conversion to laparotomy.
- •Abdominal insufflation pressure more than 14 mm Hg.
- •Medical drug allergy to paracetamol, ketoprofen and/or tramadol.
- •Presence of gastro-esophageal reflux (GERD)
- •Pregnancy
- •Patient with Thrombophilias and or at high risk of Deep Vein Thrombosis (DVT)
- •Obesity body mass index (BMI) greater than 40
- •One day surgery patients
研究组 & 干预措施
Group S
Control group (Group S: 54 patients); this group will undergo the standard laparoscopic procedure (the procedure is done in Trendelenburg position). While in Trendelenburg position and prior to wound closure and with laparoscopic port valves open, the patient's abdomen will be passively deflated. The patients will be placed in supine head up position in the post anesthesia care unit (PACU).
Group T
Intervention group (Group T: 54 patients); the patients will be subject to the same maneuver as in arm 1 prior to wound closure but will be positioned in a 20 degree Trendelenburg position once fully awake and cooperative in the PACU and will remain in this position for the first 24 hours post operatively, even after they are transferred to their rooms on the American University of Beirut Medical Center (AUBMC) floors. The maximum time allowed in a straight-up position will be three 15-minute intervals over a 24-hour period (the first interval being a clear fluids intake at 12 hours postoperatively).
干预措施: 20 degree Trendelenburg position (Procedure)
结局指标
主要结局
Shoulder pain (12 hours)
时间窗: 12 hours after laparoscopic surgery
Pain score (measured using a 0-10 numerical scale) at 12 hours
次要结局
- Shoulder pain(at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery)
- Presence of nausea(at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery)
- Severity of Nausea(at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery)
- Rescue pain medication(within first 24 hours after laparoscopic surgery)
- Total rescue pain medication(within first 24 hours after laparoscopic surgery)
- Patient satisfaction(24 hours post laparoscopic surgery)
研究者
Joseph Nassif
Assistant Professor, Department of Obstetrics & Gynecology
American University of Beirut Medical Center