跳至主要内容
临床试验/NCT07096765
NCT07096765尚未招募不适用

Effect of Injection Duration of Fascial Plane Blocks on Block Success and Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

Bursa Yüksek İhtisas Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月1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
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
sensory block distribution

研究概览

简要总结

This prospective observational study aims to evaluate the impact of injection duration during fascial plane blocks on block success and analgesic efficacy in patients undergoing laparoscopic cholecystectomy. The hypothesis is that shorter injection durations increase injection pressure, potentially limiting local anesthetic spread, while longer durations facilitate broader anesthetic distribution.

详细描述

Fascial plane blocks involve injecting local anesthetics between two anatomical fascial layers, with analgesia achieved by anesthetic diffusion through the fascial plane. However, anesthetic spread may vary significantly based on injection technique, speed, and pressure. This study hypothesizes that injection duration directly influences injection pressure, local anesthetic distribution, and consequently, the extent of sensory blockade and analgesia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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
否

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

Conventional

Active Comparator

During the fascia block application, the injection will be administered using the conventional method without any specific time limit.

干预措施: Group C (Drug)

One-minute injection

Active Comparator

During the fascia block application, the injection will be administered within 1 minute.

干预措施: Group O (Drug)

Two-minute injection

Active Comparator

During the fascia block application, the injection will be administered within 2 minutes.

干预措施: Group T (Drug)

结局指标

主要结局

sensory block distribution

时间窗: Postoperative 24 hours

The distribution of sensory block will be evaluated using pinprick and cold tests at 2, 6, 12 and 24 hours after surgery. With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.

次要结局

  • NRS(Postoperative 24 hours)
  • tramadol consumption(Postoperative 24 hours])
  • Pressure values(During the procedure)

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)

Loading locations...

相似试验