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临床试验/NCT04790292
NCT04790292已完成4 期

Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
visual analogue score(VAS) at rest and movement

研究概览

简要总结

A randomized double-blinded clinical trial was carried out on 40 patients undergoing knee arthroscopy. Patients were divided randomly into two equal groups. All drugs used were injected intra-articularly at the end of arthroscopy. In the control group, patients were administered 10mg morphine added to bupivacaine 25mg. In the study group, patients were administered 10mg morphine and 8mg dexamethasone added to bupivacaine 25mg. Visual analog score for pain at rest and movement, time to first analgesic request, total analgesic consumption, duration of analgesia and adverse effects were recorded.

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

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA) physical status I and II
  • Scheduled for minor arthroscopic knee surgeries (meniscectomy, chondroplasty, minor ligament repair and diagnostic arthroscopy)

排除标准

  • American Society of Anesthesiologists (ASA) physical status above (II)
  • Undergoing major knee surgeries
  • History of allergies to any of the used drugs
  • History of diabetes mellitus
  • Contraindications of morphine use (e.g. asthmatic patient, chronic obstructive pulmonary disease, and addiction)

研究组 & 干预措施

group M

Active Comparator

group M 10mg morphine +0.25% bupivacaine

干预措施: group M (Drug)

group MD

Active Comparator

group MD 10mg morphine + 8mg dexamethasone +0.25% bupivacaine

干预措施: group MD (Drug)

结局指标

主要结局

visual analogue score(VAS) at rest and movement

时间窗: first 24 hours post operative

visual analogue score(VAS) will be used to measure pain score (VAS score 0 cm= no pain, VAS score 10 cm = worst possible pain) when the patient is fully conscious (0) and at 2, 4, 6, 8, 10, 12, 18, 24 hours post-operatively

次要结局

  • Rescue analgesia time(first 24 hours post operative)
  • Total analgesic consumption(first 24 hours post operative)

研究者

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

Heba Fouad Abd El-Aziz Toulan

Principal Investigator

Ain Shams University

研究点 (1)

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