Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- pain postoperative
研究概览
简要总结
To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia Repair Mesh
详细描述
This study will be: controlled, prospective, randomized and double blind.
Randomized experimental study in which all patients scheduled to undergo unilateral inguinal hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be invited to participate. At the time of admission to the study, they were assigned randomly to one of the two branches of intervention:
(Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in physiological solution to a final volume of 30 ml.
(Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight + dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.
Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24 hours, 48 hours and at 8 days .
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years.
- •Unilateral inguinal hernioplasty.
- •That the surgery is performed in the Ambulatory Surgery Unit (UCA).
排除标准
- •Recurrent hernia.
- •allergies, ongoing infections, diabetes.
- •Background of rejection of prosthetic material (mesh).
研究组 & 干预措施
Bupivacaine-Dexamethasone
bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml
干预措施: Bupivacaine-Dexamethasone (Drug)
Bupivacaine- physiological solution
bupivacaine 1,5 mg/kg + physiological solution
干预措施: Bupivacaine- physiological solution (Drug)
结局指标
主要结局
pain postoperative
时间窗: 3 month
It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain.
次要结局
- take analgesic(1 month)
研究者
SEBASTIAN ROCHE
Medical Doctor
Hospital Italiano de Buenos Aires
