Effect of Abdominal Binder Use on Postoperative Shoulder Pain After Laparoscopic Gynecological Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Postoperative shoulder pain
研究概览
简要总结
The aim of the study is to evaluate the effect of the use of an abdominal binder on postoperative shoulder pain according to laparoscopic gynecological surgery. The investigators will compare the incidences of shoulder pain after laparoscopic gynecological surgery in terms of the use of an abdominal binder.
详细描述
Laparoscopic surgery has advantages over laparotomy in that it reduces postoperative pain and hospital stay. However, postoperative shoulder pain is one of the major concerns of laparoscopic surgery. Shoulder pain has been reported to occur in 35 to 70% of laparoscopic surgeries. The exact mechanism of shoulder pain after laparoscopic surgery is not clear. The main hypothesis is that the presence of residual carbon dioxide (CO2) in the abdominal cavity stimulates the diaphragmatic nerve and causes pain in the shoulder. Alveolar recruitment maneuver in the Trendelenburg position reduced the intensity and incidence of shoulder pain significantly. However, even with these measures, shoulder pain occurred in 63% of patients after surgery. In addition to this measure, The investigators hypothesized that wearing an abdominal binder would promote the absorption of residual CO2 in the abdominal cavity into the peritoneum and pelvis pressure.
The aim of this study was to evaluate the effect of the use of an abdominal binder on shoulder pain after gynecological laparoscopic surgery.
The intraoperative management is carried out in the same manner, except for wearing an abdominal binder after surgery. Laparoscopic procedure is completed, and then intraperitoneal CO2 is passive drained. An anesthetist places the operating table in the Trendelenburg position at 30 degrees and performs the alveolar recruitment maneuver. (CPAP 45 cm H2O is administered 5 times for 7 seconds) In the abdominal binder group, the patient wears an abdominal binder in the Trendelenburg position and then changed to the supine position before the emergence.
In the control group, the patient placed in the supine position, and emergence is started.
Shoulder pain at 12, 24, and 36 hours after surgery is investigated with a Numeric Score Scale (NRS) score.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 20-79 years with ASA I - III undergoing elective laparoscopic gynecological surgery under general anesthesia
排除标准
- •Patients who do not consent to the trial
- •Conversion to open surgery from laparoscopic surgery
- •Patients with previous shoulder disease or history of shoulder surgery
- •Patients who have difficulty wearing an abdominal binder due to skin disease or wounds in the abdomen
- •Development of subcutaneous emphysema
- •Change of intra-abdominal carbon dioxide pressure due to surgical difficulties
结局指标
主要结局
Postoperative shoulder pain
时间窗: Postoperative shoulder pain at 36 hours after surgery
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
次要结局
- Surgical site pain(at 12 hours, 24 hours, and 36 hours after surgery)
- Shoulder pain depending on posture(at 12 hours, 24 hours, and 36 hours after surgery)
- Incidence of postoperative nausea and vomiting (PONV)(at 12 hours, 24 hours, and 36 hours after surgery)
- Time of first walking postoperatively(After transfer to general ward up to 36 hours)
- Intensity of postoperative shoulder pain(at 12 hours, 24 hours, and 36 hours after surgery)
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital