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临床试验/NCT05971368
NCT05971368招募中不适用

A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Ultrasound Guided Serrartus Anterior Muscle Block in Video-assisted Thoracoscopic Surgeries.

Ain Shams University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年6月4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
80
试验地点
2
主要终点
visual analog scale (VAS)

研究概览

简要总结

A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard their effectiveness in post-operative analgesia

详细描述

The use of loco-regional analgesia is recommended to control postoperative pain after VATS as it allows opioid sparing and facilitates early postoperative rehabilitation. Different loco-regional analgesic techniques could be used to control pain after thoracic surgery such as a paravertebral block, an intercostal block and serratus plane block. In this study, Thoracic paravertebral nerve block will be compared to Serratus anterior nerve block, both will be done Ultrasound guided (USG) using bupivacaine (0.25%) for postoperative analgesia.

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

  • Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
  • Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.

入排标准

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

入选标准

  • Patients American Society of Anesthesiologists physical status (ASA) I to II
  • Both sexes.
  • Aged ≥ 20 to ≤ 65years.
  • Scheduled for VATS under general anesthesia.

排除标准

  • Patient's refusal.
  • Patients American Society of Anesthesiologists physical status (ASA) III to IV
  • Patients with major spine deformities.
  • Disruption of the local anatomy, secondary, for instance, to the presence of chest drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and distortion of tissue planes.
  • Patients with bleeding disorders and coagulopathy.
  • Infection at the injection site.
  • Known allergy to local anesthetics.
  • Patients with pre-existing myopathy or neuropathy.
  • Ipsilateral diaphragmatic paresis.
  • Tumors in the paravertebral space at the level of injection.

结局指标

主要结局

visual analog scale (VAS)

时间窗: the first 24 hours postoperatively

Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3

total amount of opioid consumption in the two groups according to change in VAS score

时间窗: the first 24 hours postoperatively

Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 3 will be managed by injection of nalbuphine 0.05mg / kg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)

次要结局

  • onset of ambulation(first 24 hours postoperatively)
  • The onset of 1st analgesic request(The first 24 hours postoperatively)
  • mean arterial blood pressure of the patients(first 24 hours postoperatively)
  • complication of nerve block(first 24 hours postoperatively)
  • heart rate of the patients(first 24 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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