Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy; a A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The postoperative pain
研究概览
简要总结
The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.
详细描述
The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.
The primary purpose of this study is to confirm the reduce of postoperative pain through the oral supplement of Vitamine C before and after the surgery. For this purpose, we compared the dosage or counts of opioids usage with the oral supplement of Vitamine C or not.
The secondary purpose is to assess the pain score, postoperative morbidities, postoperative length of stay or postoperative time between 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
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic cholecystitis
- •gallbladder polyp
排除标准
- •grade I Tokyo guideline for acute cholecystitis
- •grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation
- •gallbladder cancer
- •the patient who underwent reduced port surgery
- •the patient who underwent common bile duct exploration during the operation
- •the patient who underwent concurrent operation
- •the patient who had past history of upper abdominal surgery
- •the patient who had a immunodeficiency state
- •the case which had a suspicion of delayed bile leakage
- •the case which had a incomplete cystic duct ligation
- •the patient who underwent open conversion surgery during the operation
- •the patient who had a high risk of bleeding
研究组 & 干预措施
Vitamin C
During the period of hospitalization, Intake of vitamin C 3000 mg per day via oral route until the day of discharge.
After discharge, no additional vitamin C pill was given.
干预措施: Vitamin C (Drug)
Placebo
During the period of hospitalization, Intake of gelatinous capsule three times per day via oral route until the day of discharge.
After discharge, no additional capsule was given.
干预措施: Placebo (Drug)
结局指标
主要结局
The postoperative pain
时间窗: The change of pain score between 6hours after operation and 24hours after operation
Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.
次要结局
- Postoperative morbidity(30 days)
研究者
Taeho Hong
Professor
Seoul St. Mary's Hospital