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临床试验/NCT03007927
NCT03007927已完成4 期

Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh

SEBASTIAN ROCHE1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml

干预措施: Bupivacaine-Dexamethasone (Drug)

Bupivacaine- physiological solution

Active Comparator

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

发起方
SEBASTIAN ROCHE
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SEBASTIAN ROCHE

Medical Doctor

Hospital Italiano de Buenos Aires

研究点 (1)

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