跳至主要内容
临床试验/NCT04782960
NCT04782960Unknown不适用

The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia

Fayoum University0 个研究点目标入组 40 人开始时间: 2021年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
主要终点
Visual analog scale (VAS) pain score

研究概览

简要总结

This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.

详细描述

40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.

研究设计

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

入排标准

年龄范围
14 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients aged 14 _30 years old with body mass index 18_28kg/m.
  • American Anaesthesiologist Association physical states I,II.
  • singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.

排除标准

  • were patients with chronic pain.
  • ocular hypertension.
  • inability to communicate.
  • history of hematological disease.
  • allergy to local anesthetic drugs.

研究组 & 干预措施

20 patients receive Subconjunctival bupivacaine of the end of the surgery

Active Comparator

20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score

干预措施: Iocal anaesthetic bupivacaine (Drug)

20 patients receive Subconjunctival placebo in the end of operation

Placebo Comparator

20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score

干预措施: Placebo (Drug)

结局指标

主要结局

Visual analog scale (VAS) pain score

时间窗: 5 minutes after extubation

Range, 0_10;0,no pain ;10,worst pain

次要结局

  • Nausea and vomiting(24 hours postoperatively)

研究者

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

abeer shaban

Lecture of Anesthesiology

Fayoum University

相似试验