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临床试验/NCT03231215
NCT03231215已完成不适用

The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery

Assiut University0 个研究点目标入组 50 人开始时间: 2016年7月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
duration of postoperative analgesia (NRS)

研究概览

简要总结

The purpose of this study was to evaluate the efficacy of dexamethasone when added to epidural bupivacaine on the duration of postoperative analgesia in patients underwent total knee replacement surgery.

详细描述

Fifty patients underwent total knee replacement were included in the study. The patients (11 male and 39 female) were classified into two equal groups:- The patients received 15 mL plain bupivacaine + 2 mL (BS), or 8 mg dexamethasone (BD). The total volume injected in both groups was 17 ml.

Postoperative records:

  1. Pain score (NRS) at base line, then every 4 hrs for 24 hrs.
  2. Frequency of rescue analgesia.
  3. Postoperative side effects like nausea, vomiting, and over sedation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • Patients scheduled for total knee replacement surgery.
  • ASA Physical status I,II,III.
  • Exclusion Criteria
  • Patients' refusal.
  • Uncooperative patients / Not able to understand pain assessment test.
  • Patients with history of allergy to the used drugs.
  • Significant liver disease.
  • Any contraindication for epidural anesthesia
  • Failed technique.

排除标准

  • 未提供

研究组 & 干预措施

controlled group

Placebo Comparator

Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).

干预措施: Dexamethasone (Drug)

dexamethasone group

Active Comparator

Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)

干预措施: Dexamethasone (Drug)

结局指标

主要结局

duration of postoperative analgesia (NRS)

时间窗: 24 hrs postoperative

first patient request for analgesia or NRS 4 or more

次要结局

未报告次要终点

研究者

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

Mohamed galal aly

Assistant Professor

Assiut University

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