A Prospective Randomized Clinical Trial for Comparing Postoperative Pain Following COX-2 and Prostanoids Expression in Women Who Underwent Laparoscopic Surgery for Female Genital Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of biomarkers expression according to exposure to CO2 gas
研究概览
简要总结
The purpose of this study is to compare postoperative pain following COX-2 and prostanoids expression in women who underwent laparoscopic surgery for female genital disease in order to evaluate the effect of COX-2 on local inflammation, COX-2 and prostanoids expression followed by exposure time to carbon dioxide(CO2) gas, and degree of postoperative pain.
详细描述
In women who underwent laparoscopic surgery for female genital disease, the effect of COX-2 on local inflammation was assessed by randomization, using the COX-2 inhibitor celecoxib and placebo, comparative evaluation of expression of COX-2 and prostanoids by pre/postoperative peritoneal biopsy and postoperative pain depending on gas exposure time
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, Age ≥ 20 years
- •Patients with benign female genital disease who need laparoscopic surgery
- •Patients with benign disease who can be treated by single port laparoscopy
- •Patients who signed an approved informed consent
排除标准
- •Female, Age < 20 years
- •Pregnancy
- •Previous cancer history
- •Patients who refuse to sign an informed consent
- •Patients with benign female genital disease combined clinical peritonitis (ex. tubo-ovarian abscess, tubo-ovaritis, ruptured endometriosis)
- •Patients with malignant female genital disease
- •Patients who got surgery with multi-port laparoscopy
- •Patients who are contraindicated with COX-2 inhibitors (liver disease, renal disease, active peptic ulcer, active gastrointestinal tract bleeding, ischemic heart disease, hyperkalemia)
研究组 & 干预措施
COX-2 inhibitor (Celecoxib)
Celebrex; COX-2 inhibitor
干预措施: COX-2 inhibitor (Drug)
COX-2 inhibitor (Celecoxib)
Celebrex; COX-2 inhibitor
干预措施: Preoperative peritoneal biopsy (Procedure)
COX-2 inhibitor (Celecoxib)
Celebrex; COX-2 inhibitor
干预措施: Single-port laparoscopic surgery (Procedure)
COX-2 inhibitor (Celecoxib)
Celebrex; COX-2 inhibitor
干预措施: Postoperative peritoneal biopsy (Procedure)
Placebo drug (Ramnos)
Ramnos; Lactobacillus casei variety rhamnosus
干预措施: Placebo Oral Tablet (Drug)
Placebo drug (Ramnos)
Ramnos; Lactobacillus casei variety rhamnosus
干预措施: Preoperative peritoneal biopsy (Procedure)
Placebo drug (Ramnos)
Ramnos; Lactobacillus casei variety rhamnosus
干预措施: Single-port laparoscopic surgery (Procedure)
Placebo drug (Ramnos)
Ramnos; Lactobacillus casei variety rhamnosus
干预措施: Postoperative peritoneal biopsy (Procedure)
结局指标
主要结局
Change of biomarkers expression according to exposure to CO2 gas
时间窗: Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours)
Peritoneal biopsy and real-time polymerase chain reaction(RT-PCR), Immunohistochemistry of Biomarkers (COX-2, PGE2, PGF2, PGI2, TXA2)
次要结局
- Visual analogue scale(VAS) score(every six hours for 48 hours)
- Numbers of rescue analgesia(From postoperation state to discharge (up to 2 days))
- Postoperative complication(From postoperation state to discharge (up to 2 days))
- Duration of hospitalization(From postoperation state to discharge (up to 2 days))
研究者
Hee Seung Kim
Associate Professor
Seoul National University Hospital