跳至主要内容
临床试验/NCT05932186
NCT05932186尚未招募4 期

Interscalene Block Versus Upper Trunk Block in Shoulder Arthroscopy: Randomized Comparative Study of the Ease Between the Two Techniques Among Residents

Alexandria University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年7月15日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Success rate of upper trunk block and interscalene block

研究概览

简要总结

The study compares between the success rate of interscalene block and upper trunk block performed by anesthesia trainee for intra and postoperative analgesia during shoulder arthroscopy. The duration of performing the block, guidance intervention by the consultant and block failure will be recorded.

详细描述

Investigators hypothesize that upper trunk block (UTB) is not inferior to interscalene brachial plexus block (ISB) regarding analgesia, easier to perform, with superior success rates, and less side effects in shoulder arthroscopy surgeries when undertaken by anaesthesia trainee.

A sample of 120 patients {60 patients in ISB group and 60 patients in UTB group} is needed to detect difference in 20% in rate of success of block also this sample is sufficient to detect difference in {Duration of the block performance, visualization of the anatomic structures and Consultant guidance, with a power 80% at a significance level of 05. Sample size was calculated using Number Cruncher Statistical Systems (NCSS) 2004 and Process Automation Software System (PASS) 2000 program Patients will be excluded if they have severe pulmonary disease, allergy to any of the study medications, local infection at any of the puncture sites, chronic gabapentin or pregabalin use, chronic opioid use, preexisting neuropathy of the operative limb, herniated cervical disc, or body mass index more than 35 kg/m2.

Upon arrival to the block room, the procedure will be explained to patients and a written informed consent will be obtained. Patients will be randomly categorized into two equal groups (group ISB and group UTB) using a numbered sealed envelope method. All blocks will be performed guided by a 5-13 MHz linear ultrasound (US) probe of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine.

Baseline diaphragmatic assessment will be performed before the nerve block in the sitting position. A curved array 3-5 MHz transducer of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed inferior to the costal margin in a longitudinal orientation at the anterior axillary line on the left or in the midclavicular line on the right. The ultrasound beam will be directed medially and cephalad to visualize the posterior third of the hemi-diaphragm by using either the spleen or the liver as an acoustic window, relatively. First the view will be obtained in a two-dimensional B-mode then the M-mode sonography will be used to quantify the extent of diaphragmatic excursion between full inspiration and full expiration once a view of the curved, hyperechoic diaphragmatic line has been obtained. This assessment will be carried out by the research anaesthetist.

Blocks will be carried out by anaesthesia residents who have one year experience in ultrasound guided regional anesthesia under direct supervision of a consultant anaesthetist (After demonstrating five successive blocks in each technique). Patients, surgeons, and the research anaesthetist will be blinded to the block technique.

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
Single (Participant)

盲法说明

Single blinded

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18 to 75 years
  • •American Society of Anesthesiologists physical status I to III
  • •Scheduled for arthroscopic rotator cuff repair

排除标准

  • •Severe pulmonary disease
  • •Allergy to any of the study medications
  • •Local infection at any of the puncture sites
  • •Chronic gabapentin or pregabalin use
  • •Chronic opioid use
  • •Preexisting neuropathy of the operative limb, herniated cervical disc
  • •Body mass index more than 35 kg/m2.

研究组 & 干预措施

Interscalene block

Active Comparator

Patients will receive inter scalene brachial plexus block combined with general anesthesia

干预措施: Interscalene brachial plexus block combined with general anesthesia (Procedure)

Upper trunk block

Active Comparator

Patients will receive upper trunk brachial plexus block combined with general anesthesia

干预措施: Upper trunk brachial plexus block combined with general anesthesia (Procedure)

结局指标

主要结局

Success rate of upper trunk block and interscalene block

时间窗: 30 minutes after block performance

Sensory and motor blockade will be assessed 30 minutes after block performance. Motor block will be evaluated by asking the patient to abduct his arm and will be graded on a three-points scale (2 = normal; 1 = weakness, and 0 = complete loss of power). Sensory block will be evaluated in the C4, C5, and C6 dermatomes and will be graded on a three-points scale (2 = normal; 1 = loss of sensation to pinprick; and 0 = loss of sensation to light touch). Block success will be defined as a sensory score of 0 within 30min

次要结局

  • Guidance interventions(During the procedure)
  • Complications(24 hours postoperatively)
  • Visualization of anatomic structures(During the procedure)
  • Postoperative pain(24 hours postoperatively)
  • Opioid consumption(24 hours postoperatively)
  • Duration of performing the block(During the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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