跳至主要内容
临床试验/NCT07090733
NCT07090733招募中不适用

The Effect of Ultrasound Guided Interscalene, Suprascapular and Anterior Glenoid Nerve Blocks on Diaphragmatic Excursion and Analgesia Following Arthroscopic Shoulder Surgery: A Prospective Randomized Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Incidence of hemi-diaphragmatic paralysis

研究概览

简要总结

This study aims to evaluate the diaphragmatic movement and postoperative analgesia following anterior glenoid, suprascapular, and interscalene nerve blocks in patients undergoing elective arthroscopic shoulder surgery.

详细描述

Arthroscopic shoulder surgery is a key approach for diagnosing and treating many shoulder disorders. Nevertheless, 30-70% of patients often experience moderate to severe pain, especially at 48 h after the operation, which affects rapid recovery.

The interscalene brachial plexus block (ISB) remains the gold standard for providing analgesia after shoulder surgery. Suprascapular nerve block (SSNB) is the most commonly used regional nerve block. Seventy percent of the sensory nerve fibers of the shoulder joint are innervated by the suprascapular nerve (SSN), with the supraspinatus and infraspinatus being directly innervated by the SSN.

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)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age from 21 to 65 years.
  • •Both sexes.
  • •American Society of Anesthesiologists (ASA) physical status I or II.
  • •Scheduled for arthroscopic shoulder surgery.

排除标准

  • •Patient's refusal to participate.
  • •Patients with a history of allergy to local anesthetics.
  • •Patients with a history of chronic use of painkillers.
  • •Patients presented with mental dysfunction.
  • •Patients with coagulation disorders.
  • •Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
  • •Pregnant Patients.
  • •Patients with Chronic Obstructive Pulmonary Disease (COPD) or a Body Mass Index (BMI) of more than 40.

研究组 & 干预措施

Group I

Active Comparator

Patients will receive general anesthesia, plus an ultrasound-guided Interscalene brachial plexus block (ISB) with the injection of 15 mL of 0.25% bupivacaine.

Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB)

干预措施: Interscalene brachial plexus block (Other)

Group II

Experimental

Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) with injection of 15 ml of 0.25% bupivacaine.

干预措施: Suprascapular nerve block (Other)

Group III

Experimental

Patients will receive general anesthesia plus an ultrasound-guided anterior glenoid block with injection of 15 ml of 0.25% bupivacaine.

干预措施: Anterior glenoid block (Other)

Group IV

Experimental

Patients will receive general anesthesia, along with a total volume of 30 mL of bupivacaine 0.25%, divided into 15 mL of Bupivacaine 0.25% for ultrasound-guided SSNB and 15 mL of Bupivacaine 0.25% for ultrasound-guided anterior glenoid block.

干预措施: Suprascapular nerve block + Anterior glenoid block (Other)

结局指标

主要结局

Incidence of hemi-diaphragmatic paralysis

时间窗: 24 hours postoperatively

Incidence of hemi-diaphragmatic paralysis determined by ultrasound-guided assessment of diaphragmatic excursion. Diaphragmatic excursion will be measured before procedure (pre-block), 30 minutes after performing the block and post operative after complete recovery in post-anesthesia care unit (PACU).

次要结局

  • Degree of pain(24 hours postoperatively)
  • Total analgesic consumption(24 hours postoperatively)
  • Degree of patient satisfaction(24 hours postoperatively)

研究者

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

Fatma Elsamahy

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Tanta University

研究点 (1)

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