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临床试验/NCT05165836
NCT05165836已完成不适用

Role of Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia After Shoulder Arthroscopy: A Randomized Controlled Study

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
The total rescue morphine (mg) consumption in the first 24 post-operative hours.

研究概览

简要总结

The aim of this study is to evaluate the effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound (US) guided erector spinae plane block (ESPB) for managing acute postoperative pain in patients undergoing shoulder arthroscopy.

详细描述

Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.

There are many postoperative pain management modalities after shoulder arthroscopy including non-steroidal anti-inflammatory drugs, intraarticular injection, regional nerve blocks, patient controlled analgesia and cryotherapy.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB has been used successfully in many surgeries such as mastectomy, thoracotomies , percutaneous nephrolithotomies, lumbar fusions, hernia repair, cesarean delivery and even in total hip arthroplasty .

ESPB has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.

Dexmedetomidine is a very selective α2 adrenoceptor agonist that is tenfold more selective than clonidine. It is a highly flexible medication in anesthetic practice, finding use in an expanding range of clinical circumstances.

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
Triple (Participant, Investigator, 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

  • Patients aged 18-65 years
  • Both genders and BMI < 40 kg/m2
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Patients who are posted for elective shoulder arthroscopy

排除标准

  • Known allergy to local anesthetics
  • Allergy to all opioid medications
  • Diagnostic shoulder arthroscopic procedures,
  • Patients with chronic opioid use and coagulopathy

结局指标

主要结局

The total rescue morphine (mg) consumption in the first 24 post-operative hours.

时间窗: 24 hours postoperative

Rescue analgesia in the form of 3 mg IV morphine (mg) will be given if the numeric rating scale (NRS) score is ≥ 4 repeated with 10 minutes lockout interval till the numeric rating scale (NRS) score becomes less than 3

次要结局

  • Time to first request of rescue analgesia(24 hours Postoperative)
  • Post-operative pain score(24 hours Postoperative)

研究者

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

Mohamed Fouad Algyar

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Kafrelsheikh University

研究点 (1)

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