Comparison of Effectiveness of Preoperative Gabapentin With Celecoxib in Reducing Acute Postoperative Pain in Abdominal Hysterectomy, A Randomized Double Blindcontrolled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Subjective pain at 24 hours post operation: numeric analog scale
研究概览
简要总结
Comparison of effectiveness of preoperative Gabapentin with Celecoxib in reducing acute postoperative pain in abdominal hysterectomy, A randomized double blind controlled trial
详细描述
Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide.Some studies noticed about overused of opioids in postoperative care , leaded to more adverse effect of opioids , slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment.
ERAS guidelines has considered to use preoperative analgesics for reducing post-operative opioids consumption, including Gabapentin and Celecoxib.
Gabapentin and celecoxib widely used for treatment of pain and many studies have demonstrated the preoperative efficacy and safety of Gabapentin and Celecoxib in variety procedures involving hysterectomy.However, no definite conclusion of optimal dose and timing for preopearive uptake ,apart from no good evidences based supported preoperative Gabapentin or Celecoxib in hysterectomy in Thailand . In addition, the protocol for preoperative analgesics in hysterectomy, has not been performed in the investigator's center.
Therefore the aim of this study is to assess and compare the efficacy and safety of preoperative Gabapentin and Celecoxib to reduce acute postoperative pain in non-gynecological cancerous woman undergoing total abdominal hysterectomy
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ranging age between 18-65 years and having non-gynecological cancerous women who undergoing elective total abdominal hysterectomy
- •Women who has ASA physical status I-II
- •Women who agrees to participate in this study
排除标准
- •Women who pregnancy
- •Women who have abnormal kidney function test (Cr > 1.5 )
- •Women who have abnormal liver function test
- •Women with history or present of thrombosis such as myocardial infarction, ischemic stroke, deep venous thrombosis or pulmonic embolism
- •Women with history of gastrointestinal bleeding -Women with history of gastrointestinal bleeding -Women with history of gastrointestinal bleeding
- •Women who take the antiplatelet or anticoagulant medications
- •Women with history of allergy to Gabapentin ,Celecoxib and Sulfa
- •Women who have used or known Gabapentin or Celecoxib before
- •Women who have chronic alcoholism
- •Women who underwent previous surgery
- •Women who undergo extended low midline incision
- •Women who undergo lysis adhesion
- •Women who undergo further operations except salpingo-oophorectomy
- •Women who cannot evaluated pain score
研究组 & 干预措施
Gabapentin Group
Subjects will receive Gabapentin 600 mg (two capsules of Gabapentin 300 mg) at two hours prior to surgery with clear water 30 ml and undergo elective total abdominal hysterectomy
干预措施: Total abdominal hysterectomy (Procedure)
Celecoxib Group
Subjects will receive Celecoxib 400 mg (two capsules of Celecoxib 200 mg) at two hours prior to surgery with clear water 30 ml and undergo elective total abdominal hysterectomy
干预措施: Total abdominal hysterectomy (Procedure)
Placebo group
Subjects will receive Placebo (two capsules of placebo) at two hours prior to surgery with clear water 30 ml and undergo elective total abdominal hysterectomy
干预措施: Total abdominal hysterectomy (Procedure)
结局指标
主要结局
Subjective pain at 24 hours post operation: numeric analog scale
时间窗: During acute post operation peroid as 24 hours post operation
Assessment of subjective pain score post operation at 24 hours (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery ),by using a numeric analog pain scale from .Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid
次要结局
- Adverse effects of Gabepentin and Celecoxib at 24 hours post operation(During acute post operation peroid as 24 hours post operation)
- First opioid rescue dose at 24 hours post operation(During acute post operation peroid as 24 hours post operation)
- Opioid consumption at 24 hours post operation (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery )(During acute post operation peroid as 24 hours post operation)
- Subjective pain at the time of discharge: numeric analog pain scale(Date of discharge ,not longer than 7 days after admit)
- Length of hospitalization stay(Date from of admit to date of discharge,not longer than 7 days after admit)