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临床试验/NCT04492319
NCT04492319已完成不适用

The Effect of Addition of Neostigmine to Levobupivacaine in Male Patients Receiving Ultrasound Guided Spermatic Cord Block for Postoperative Analgesia in Testicular Sperm Extraction Surgery:

Cairo University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2020年9月29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
112
试验地点
1
主要终点
Time from end of surgery to the first postoperative analgesic request

研究概览

简要总结

Using the spermatic cord block has been of great advantage, as it has been cost saving, efficient technique whether used inon its own or combination with a sedative or . Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic cord block is being a single injection technique, leading to a short postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia duration as neostigmine.

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
20 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients aged from 20 to 45 years.
  • American Society of Anesthesiologists I-II.
  • Undergoing Testicular Sperm Extraction Surgery.
  • BMI from 18.5 to 40 kg/m2

排除标准

  • Patient refusal
  • Contraindications to regional anesthesia (bleeding disorders e.g. international normalized ratio >1.5, Prothrombin Concentration <70%, platelet count<100 × 109, use of any anti-coagulants, local infection, etc.).
  • Known allergy to local anesthetics.
  • ASA III-IV.
  • Patients aged less than 18 or more than
  • Body mass index >35.:

研究组 & 干预措施

control group

Active Comparator

干预措施: Control Test (Drug)

neostigmine group

Active Comparator

干预措施: Neostigmine (Drug)

结局指标

主要结局

Time from end of surgery to the first postoperative analgesic request

时间窗: UP TO 24 HOURE

(duration of the block).

次要结局

  • spermatic cord block time(UP TO 1 HOURE)
  • visual analog scale(UP TO 24 HOURE)
  • Incidence of complications(up to 24 hours)
  • Postoperative analgesic use(up to 24 hours)

研究者

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

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Cairo University

研究点 (1)

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