跳至主要内容
临床试验/NCT05083793
NCT05083793Unknown2 期

The Effect of Pregabalin on Post-operative Pain and Opioid Consumption in Spine Surgery, a Prospective, Randomized, Controlled Study

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
90
试验地点
1
主要终点
Morphia dose

研究概览

简要总结

The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study

详细描述

Aim of the work:

The aim of our study is to compare the analgesic effect of pre-emptive oral pregabalin 150mg on acute postoperative pain and opioid consumption in spine surgery. Evaluated by visual analog scale (VAS)

primary outcome measure is the total amount of rescue morphine received by patients for 24h postoperatively.

secondary outcome measures include level of acute postoperative pain by VAS, and duration of hospital stay

Patients and methods :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

盲法说明

care provider

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • : This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery

排除标准

  • : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.

研究组 & 干预措施

Study group

Experimental

patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery

干预措施: Pregabalin 150mg (Drug)

Placebo group

Placebo Comparator

patients will receive placebo 1 hour before surgery with a sip of water.

干预措施: Placebo (Other)

结局指标

主要结局

Morphia dose

时间窗: 24 hour postoperative

the total amount of rescue morphine received by patients for 24h postoperatively.

次要结局

  • Postoperative pain(24 hour postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed galal aly

Professor of anesthesia and intensive care

Assiut University

研究点 (1)

Loading locations...

相似试验