NCT06039150Enrolling By Invitation不适用
Medical Doctor of Anesthesiology and Reanimation
Gulhane Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Total number of rescue analgesic applications
研究概览
简要总结
To compare the effect of M-TAPA block and port-site local anesthetic infiltration on postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to answer are:
- Is M-TAPA block more effective in reducing pain?
- How M-TAPA block affects the use of rescue analgesics in the postoperative period? Participants will have the same anaesthetic agents during surgery, before extubation they will have same analgesic agent for postoperative pain. Participants in the M-TAPA group will undergo USG-guided M-TAPA block bilaterally with % 0.025 Bupivacaine max dose of 2 mg/kg by the same experienced anesthesiologist before extubation. Participants in the LAI group will be administered 0.025% Bupivacaine at a maximum dose of 2mg/kg divided equally and administered by the surgeon at 3 port entry sites before the patient is extubated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with American society of Anesthesiologists (ASA) physical status I-II,
- •Patients which will undergo Laparoscopic appendectomy due to the diagnosis of acute appendicitis,
- •Patients whose parents or legal heirs have consented to participate in the study
排除标准
- •Patients with Society of Anesthesiologists (ASA) III-IV status,
- •Patients whose parents or legal heirs' disapproval,
- •Patients inability to cooperate,
- •Patients who have allergy to any of the medications used in the study,
- •Patients with perforated appendix
- •When the Laparoscopic surgery returns to open shape
结局指标
主要结局
Total number of rescue analgesic applications
时间窗: Postoperative first 24 hours
During the first 24 hours postoperatively, patients' pain will be monitored by Visual Analogue Scale (VAS) scoring. Paracetamol will be given intravenously at a dose of 10mg/kg if the VAS is greater than 4 in pain assessment in the postoperative period. We will record the number of times the patient received rescue analgesics over a 24-hour period.
次要结局
- Comparison of pain between 2 groups in the postoperative period(Postoperative first 24 hours)
研究者
ELA ERTEN
Medical Doctor
Gulhane Training and Research Hospital
研究点 (2)
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