跳至主要内容
临床试验/NCT06008002
NCT06008002已完成不适用

Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study

Bursa Yüksek İhtisas Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年8月25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
发起方
入组人数
90
试验地点
1
主要终点
NRS

研究概览

简要总结

Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.

详细描述

In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (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

  • laparoscopic cholecystectomy surgery
  • Patients with ASA (American Society of Anaesthetists) scores I and III will be included.

排除标准

  • Uncontrolled Arterial Hypertension
  • Uncontrolled Diabetes Mellitus,
  • Mental retardation ,
  • Antidepressant use
  • Metabolic disorders,
  • Bleeding diathesis
  • Patients with a body mass index above 30.

研究组 & 干预措施

Group M

Active Comparator

ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block

干预措施: M-TAPA block (Procedure)

Group M

Active Comparator

ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block

干预措施: Tramadol (Drug)

Group E

Active Comparator

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block

干预措施: EXORA block (Procedure)

Group E

Active Comparator

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block

干预措施: Tramadol (Drug)

Group P

Active Comparator

Patient-controlled analgesia with tramadol

干预措施: Tramadol (Drug)

结局指标

主要结局

NRS

时间窗: Postoperative 24 hours

The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

次要结局

  • side effect profile scores(Postoperative 24 hours)
  • tramadol consumption(Postoperative 24 hours)
  • Ramsay Sedation Scale(Postoperative 24 hours)
  • additional analgesic use(Postoperative 24 hours)
  • pinprick test(Postoperative 24 hours)

研究者

发起方
Bursa Yüksek İhtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Korgün Ökmen

Principal Investigator

Bursa Yüksek İhtisas Education and Research Hospital

研究点 (1)

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