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临床试验/NCT07670780
NCT07670780尚未招募不适用

Comparison of the Effects of Interscalene Block and Infraspinatus-Teres Minor Interfascial Plane Block on Postoperative Analgesia and Diaphragmatic Function in Patients Undergoing Shoulder Arthroscopy.

TC Erciyes University0 个研究点目标入组 120 人开始时间: 2026年6月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Diaphragmatic Excursion

研究概览

简要总结

This prospective randomized controlled study aims to compare the effects of interscalene block, infraspinatus-teres minor interfascial plane block, and a control group on postoperative analgesia and diaphragmatic function in patients undergoing shoulder arthroscopy. A total of 120 patients will be enrolled and allocated into three groups. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and diaphragmatic function will be evaluated and compared among the groups. The study seeks to determine whether the infraspinatus-teres minor interfascial plane block can provide effective postoperative analgesia with less impact on diaphragmatic function compared with interscalene block.

详细描述

Shoulder arthroscopy is associated with significant postoperative pain. Interscalene block is widely used for analgesia but may impair diaphragmatic function because of phrenic nerve involvement. The infraspinatus-teres minor interfascial plane block has been proposed as an alternative regional anesthesia technique that may provide adequate analgesia while preserving diaphragmatic function. This randomized controlled trial will include 120 adult patients undergoing elective shoulder arthroscopy. Participants will be randomized into three groups: interscalene block, infraspinatus-teres minor interfascial plane block, and control. Pain scores, opioid consumption, time to first rescue analgesia, diaphragmatic excursion measured by ultrasound, and block-related complications will be recorded and analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and outcome assessors are blinded to group allocation.

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

  • Age between 18 and 65 years
  • ASA physical status I-II
  • Scheduled for elective shoulder arthroscopy
  • No known allergy to study medications
  • No psychiatric disorder
  • No opioid dependence
  • Ability to use patient-controlled analgesia (PCA) and complete VAS assessments
  • No contraindication to peripheral nerve blocks
  • Written informed consent obtained

排除标准

  • Refusal to participate
  • Uncontrolled hypertension
  • Chronic pain or ongoing analgesic treatment
  • Significant cardiac disease (coronary artery disease, arrhythmia, heart failure)
  • Diabetes mellitus

研究组 & 干预措施

Infraspinatus-Teres Minor Interfascial Plane Block Group

Experimental

Patients receive ultrasound-guided infraspinatus-teres minor interfascial plane block for postoperative analgesia after shoulder surgery.

干预措施: Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane Block (Procedure)

Control Group

No Intervention

Interscalene Block Group

Experimental

Patients receive ultrasound-guided interscalene brachial plexus block for postoperative analgesia following shoulder surgery.

干预措施: Ultrasound-Guided Interscalene Block (Procedure)

结局指标

主要结局

Diaphragmatic Excursion

时间窗: 24 hours after surgery

Comparison of postoperative diaphragmatic excursion measured by ultrasonography between study groups.

Postoperative Pain Intensity

时间窗: 0, 2,4, 6, 12, and 24 hours after surgery

Postoperative pain intensity assessed using the Visual Analog Scale (VAS) , ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. higher scores indicate greater pain intensity. compared between study groups.

次要结局

未报告次要终点

研究者

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

Recep Aksu

Professor

TC Erciyes University

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