Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The change of shoulder pressure pain threshold
研究概览
简要总结
This prospective, double blind, placebo-controlled, parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, estimated 120 patients will be involved in this study. All eligible patients will be randomly assigned to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive normal saline at the same time points. The shoulder pressure pain thresholds will be measured with a pressure algometer by an independent doctor blinding to medication and grouping at the day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At the end of the observation, the intensity of the maximal shoulder pain will be assessed.
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
- Triple (Participant, Care Provider, 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
- •females age 18-65yr,
- •American Society of Anesthesiologists (ASA)I-II,
- •Body Mass Index(BMI) 18-25kg/m2.
排除标准
- •a history of severe cardiac, pulmonary, hepatic, renal disease, chronic drug or alcohol abuse;
- •the presence of preoperative shoulder pain or any chronic pain syndrome, long-term use of analgesics; allergy or contraindications to nonsteroidal anti-inflammatory drugs (allergy, peptic ulcer disease, gastroesophageal reflux disease, renal insufficiency, coagulopathy) and any other drugs used in the study;
- •patient's pain evaluation is judged unreliable;
- •patients with conversion to a laparotomy;
- •refuse to coordinate with the follow-up tests.
研究组 & 干预措施
Parecoxib
Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery.
干预措施: Parecoxib (Drug)
Placebo
Normal saline 5ml will be intravenously infused at the same time points., respectively.
干预措施: Placebo (Drug)
结局指标
主要结局
The change of shoulder pressure pain threshold
时间窗: The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery
The patients keep sitting position, and the pressure pain thresholds are measured twice at a fixed point in bilateral levator scapulae, supraspinatus, pectoralis major and flexor carpi ulnaris with a pressure algometer (FPX25, Wagner Instruments, USA) by an independent doctor.
次要结局
- The severity of shoulder pain(At the day before surgery, 24h and 48h after surgery)
研究者
Xuyu Zhang
Attending Doctor
First Affiliated Hospital, Sun Yat-Sen University