NCT06638112已完成不适用
Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy: Brachial Plexus Block for Pain Control Under General Anesthesia Versus Brachial Plexus Block for Surgical Block Under Sedation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Quality of recovery (QoR-15) at 48 hours post-surgery
研究概览
简要总结
The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:
- general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
- regional anesthesia (brachial plexus block) with intraoperative sedation.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery
排除标准
- •emergency operation
- •inflammation or infection at the site of nerve block administration
- •inability to perform the quality of recovery questionnaire due to dementia or delirium
- •severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease)
- •contraindication to brachial plexus block
- •history of hypersensitivity or side effect to ropivacaine
研究组 & 干预措施
General anesthesia
Active Comparator
The patient undergoes shoulder arthroscopy under general anesthesia after receiving a preoperative brachial plexus block for intra- and postoperative analgesia.
干预措施: General Anesthesia (control group) (Procedure)
Brachial plexus block
Experimental
The patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol.
干预措施: Brachial Plexus Block (Procedure)
结局指标
主要结局
Quality of recovery (QoR-15) at 48 hours post-surgery
时间窗: at 48 hours post-surgery
Quality of recovery (QoR-15) at 48 hours post-surgery (0-150)
次要结局
- Antiemetic administration(rom end of surgery up to 48 hours post-surgery)
- Baseline hemidiagphramatic paralysis(On the day of surgery, before the operation)
- Postoperative hemidiagphramatic paralysis(Immediately after surgery)
- Quality of recovery (QoR-15) on the day before surgery(on the day before surgery)
- Quality of recovery (QoR-15) 24 hours post-surgery(at 24 hours post-surgery)
- Postoperative pain 1 hour post-surgery(at 1 hour post-surgery)
- Postoperative pain 6 hours post-surgery(at 6 hours post-surgery)
- Postoperative pain 12 hours post-surgery(at 12 hours post-surgery)
- Postoperative pain 24 hours post-surgery(at 24 hours post-surgery)
- Postoperative pain 48 hours post-surgery(at 48 hours post-surgery)
- Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery(at 1 hour post-surgery)
- Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery(at 6 hours post-surgery)
- Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery(at 12 hours post-surgery)
- Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery(at 24 hours post-surgery)
- Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery(at 48 hours post-surgery)
- Rescue opioid analgesic administration(from end of surgery up to 48 hours post-surgery)
研究者
研究点 (1)
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