Evaluation of Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine for Augmenting Analgesia and Anesthesia in Ultrasound Guided Spermatic Cord Block For Testicular Sperm Extraction Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Time from injection of LA 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 Dexmetedomidine (Dex), and magnesium.
详细描述
The technique of the spermatic cord block was first described in the 1960s by Earle AS.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 Dexmetedomidine (Dex), and magnesium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Prospective randomized double blinded clinical study on humans
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients aged from 18 to 60 years.
- •ASA I-II.
- •Undergoing Testicular Sperm Extraction Surgery.
- •BMI from 18.5 to 30 kg/m2
排除标准
- •Patient refusal
- •Contraindications to regional anesthesia (bleeding disorders e.g. INR>1.5, PC<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 >
- •Patients with difficulty in evaluating their level of pain.
研究组 & 干预措施
cotrol group
干预措施: Control Test (Drug)
dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
magnesium sulphate group
干预措施: magnesium sulphate (Drug)
dexmedetomidine and magnesium sulphate group
干预措施: Dexmedetomidine and magnesium sulphate (Drug)
结局指标
主要结局
Time from injection of LA to the first postoperative analgesic request
时间窗: UP TO 1 HOURE
(duration of the block).
次要结局
- perform SCAB(UP TO 1 HOURE)
- Incidence of complications(up to 24 hours)
- total nalbuphine consumption(up to 24 hours)
- mean arterial blood pressure(up to 24 hours)
- heart rate(up to 24 hours)
- VAS(up to 24 hours)
研究者
Amr Samir Wahdan
Lecturer of Anesthesia, Pain management and Surgical ICU
Cairo University