临床试验/NCT03601780

NCT03601780Unknown2 期

Effect of Local Wound Infiltration Plus Usual Care Versus Usual Care Alone on Pain Relief After Open Renal Surgery.

Assiut University0 个研究点目标入组 40 人开始时间: 2018年8月最近更新: 2018年7月26日

适应症

干预措施

试验速览

阶段: 2 期
发起方: Assiut University
入组人数: 40
主要终点: Postoperative pain

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Multimodal analgesia is a rational approach to treat various components of postoperative pain.

详细描述

Local anesthetic wound infiltration is widely recognized as a useful adjunct during multimodal postoperative pain management whether given before operation or perioperatively.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 30 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•ASA I or II, aged between 30 and 65 yr, and undergoing open renal surgery

排除标准

•history of adverse reactions to local anaesthetics, chronic hepatic disease, chronic renal disease chronic pain, chronic preoperative opioid consumption, psychiatric disorders which would prevent postoperative assessments,

研究组 & 干预措施

Local wound infiltration

Active Comparator

local wound infiltration plus usual care

干预措施: local wound infiltration plus usual care (Drug)

Control

Placebo Comparator

usual care only

干预措施: usual care only (Drug)

结局指标

主要结局

Postoperative pain

时间窗: The first 48 hours after surgery

Visual analogue scale ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.

次要结局

未报告次要终点

研究者

发起方

Assiut University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Seham Mohamed Moeen Ibrahim

lecturer

Assiut University

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