Bupivacaine Versus Meloxicam Infiltration on Post Cesarean Section Pain Relief
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Postoperative analgesic requirements
研究概览
简要总结
Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement.
Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable
详细描述
study type: randomized clinical trial actual enrollment: 119 allocation: Random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after Cesarean section actual study start: March 3, 2019 Primary Completion: March 5, 2020 actual study completion date: May 9, 2020
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, Investigator)
盲法说明
Each woman received a disposable syringe containing a medication corresponding to her order of participation in the trial. Packing. Sealing and numbering were performed by health care provider who did not actively share in the process of the study.
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 21-40 years
- •Elective C.S at term
- •Patient having no medical disorders
- •Patient with no obstetrical complications
排除标准
- •extreme of reproductive age
- •allergy to local anesthetic infiltration agent
- •any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia
- •refusal to participate in the trial.
研究组 & 干预措施
bupivacaine group
included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline.
干预措施: local ifiltration Bupivacaine, Meloxican and placebo (Drug)
meloxicam group
included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline.
干预措施: local ifiltration Bupivacaine, Meloxican and placebo (Drug)
placebo group
included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.
干预措施: local ifiltration Bupivacaine, Meloxican and placebo (Drug)
结局指标
主要结局
Postoperative analgesic requirements
时间窗: immediately after the intervention
Assessment of Postoperative analgesic requirements
time of first dose of analgesia
时间窗: immediately after the intervention
Determination of time of first dose of analgesia
Postoperative pain scores
时间窗: immediately after the intervention
Assessment of pain scores after Cesarean section
次要结局
- Postoperative fever(immediately after the intervention)
- side effects of medications(immediately after the intervention)
- onset of mobilization(immediately after the intervention)
- Pain assessment by visual analogue scale(immediately after the intervention)
研究者
Mohamed Elsibai Anter
Lecturer of obstetrics and gynecology
Menoufia Obstetrics and Gynecology Group