跳至主要内容
临床试验/NCT04194385
NCT04194385招募中不适用

Comparison of Perioperative Analgesic Efficacy of Ultrasonography Guided Upper Trunk Block and Costoclavicular Infraclavicular Brachial Plexus Block in Arthroscopic Shoulder Surgery

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Detection of diaphragmatic paralysis by ultrasonography

研究概览

简要总结

Interscalene brachial plexus block is known as the gold standard for analgesia after shoulder surgery, but limits the use of ipsilateral phrenic nerve paralysis. Recently, interest in potential diaphragm-sparing alternative blocks has increased for patients undergoing shoulder surgery.Two of these blocks are upper trunk block (UTB) and costoclavicular brachial plexus (CCBPB) block. This randomized controlled trial will compare ultrasound-guided UTB and CCBPB in patients undergoing arthroscopic shoulder surgery.

The main outcome is pain intensity score at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rating scale (NRS) from 0 to 10. The investigators research hypothesis is that UTB and CCBPB will result in equivalent postoperative analgesia at 30 minutes in the PACU.

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, Care Provider)

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

  • American Association of Anesthesiologists (ASA) physical status I - III
  • BMI 20 to 35 kg / m2
  • Patients scheduled for elective arthroscopic shoulder surgery

排除标准

  • Patients who refuse to participate in the study,
  • Pre-existing (obstructive or restrictive) lung disease,
  • Coagulopathy,
  • Hepatic or renal insufficiency,
  • Allergy to local anesthetic drugs,
  • Chronic pain condition requiring opioid intake at home,
  • Surgery in the neck or infraclavicular region
  • History of psychiatric diseases needing treatment.
  • Failure of nerve block performed in the preoperative block room
  • Substance abuse history

结局指标

主要结局

Detection of diaphragmatic paralysis by ultrasonography

时间窗: 30 minutes after block application

Ipsilateral diaphragmatic excursion 30 minutes after block completion

次要结局

  • Block perform time(The time from the needle enters the skin until the block is completed)
  • Postoperative opioid consumption(24 hour after surgery)
  • Block onset time(Until sensory and motor block occurs)
  • Pain intensity score(30 minutes, 1,3, 6, 12, 24 hour after surgery)
  • Patient satisfaction: NRS(24 hour after surgery)
  • Intraoperative fentanyl requirement(From the beginning to the end of the operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Upper Trunk Block Versus Costoclavicular Block For... | 临床试验