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临床试验/NCT06826846
NCT06826846已完成不适用

Comparison of the Analgesic Effects of Catheter-Based and Single-Shot Serratus Posterior Superior Intercostal Plane Block Versus No Block in Arthroscopic Shoulder Surgery

Goztepe Prof Dr Suleyman Yalcın City Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Postoperative Opioid Consumption

研究概览

简要总结

Patients undergoing arthroscopic shoulder surgery often experience moderate to severe postoperative pain. Various medical treatments are employed to provide analgesia for these patients. The advancement of regional anesthesia techniques has made possible to both reduce the use of narcotic analgesics and provide long-term pain management benefits.

The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) was first described in 2023 by Serkan Tulgar et al. Cadaveric studies and dermatomal analyses in patients have demonstrated its ability to provide analgesia in the back, neck, shoulder, axilla, and lateral thoracic regions.

Even though patients undergoing shoulder surgery benefit from the block; once the duration of a single-shot block wears off, they may experience severe pain again. The aim of this study is to investigate the analgesic effects of a single-shot SPSIPB compared to catheter-based SPSIPB with intermittent postoperative bolus administration provided by placing a catheter in this region.

The hypothesis of this study: In arthroscopic shoulder surgery, the intermittent bolus administration of the serratus posterior superior intercostal plane block using a catheter will result in lower pain scores, reduced opioid consumption, and improved patient satisfaction compared to single-shot application.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 18-80 years
  • •No bleeding diathesis
  • •Classified as ASA I-II-III

排除标准

  • •Patients who do not provide consent
  • •Patients with coagulopathy
  • •History of allergy or intoxication to local anesthetic agents
  • •Patients with advanced organ failure
  • •History of neuropathic disease
  • •Patients with mental retardation
  • •Presence of infection at the injection site
  • •Conditions in which regional anesthesia is contraindicated
  • •Pediatric patients and those over 80 years of age
  • •Pregnant patients

研究组 & 干预措施

Group 3: Catheter-based SPSIPB with intermittent postoperative bolus administration

Active Comparator

干预措施: Serratus posterior superior intercostal plane block (catheter-based intermittent bolus) (Other)

Group 2: Patients who will receive a single-shot serratus posterior superior plane block

Active Comparator

干预措施: Serratus posterior superior intercostal plane block (single-shot) (Other)

Group 1: This patient group will not undergo any regional block

No Intervention

结局指标

主要结局

Postoperative Opioid Consumption

时间窗: Postoperative 24 hours

Patient-Controlled Analgesia (Tramadol)

次要结局

  • Patient Satisfaction (Likert scale)(Post surgery 24 hours)
  • Postoperative Pain Scores(Postoperative 24 hours)
  • Postoperative Nausea and Vomiting Scale(24 hours)
  • Perioperative Remifentanyl Consumption(Perioperative assessment)
  • Use of Rescue Analgesics in the Ward(24 hours)

研究者

发起方
Goztepe Prof Dr Suleyman Yalcın City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ILKER YALCIN

Anesthesiology and Reanimation Resident, M.D.

Goztepe Prof Dr Suleyman Yalcın City Hospital

研究点 (1)

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