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临床试验/NCT06966011
NCT06966011招募中不适用

Pain Management After Total Knee Arthroplasty: Incidence and Outcomes of Rebound Pain

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Incidence of Rebound Pain After Peripheral Nerve Block

研究概览

简要总结

This prospective observational study aims to determine the incidence and clinical impact of rebound pain after peripheral nerve blocks in patients undergoing total knee arthroplasty. Rebound pain is defined as a sudden, severe pain (NRS ≥7) emerging after block resolution. Primary outcome is the incidence of rebound pain; secondary outcomes include pain severity, rescue analgesia use, nausea, vomiting, sleep quality, and patient satisfaction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18 and 70 years
  • •ASA physical status I to III
  • •Scheduled for elective unilateral total knee arthroplasty under spinal anesthesia
  • •Peripheral nerve block (PNB) planned as part of multimodal analgesia
  • •Ability to understand and provide written informed consent
  • •Willingness and ability to complete the postoperative pain diary

排除标准

  • •Known allergy or hypersensitivity to local anesthetics
  • •Contraindication to regional anesthesia
  • •ASA physical status IV or higher
  • •Neurological or psychiatric disorders interfering with study participation or pain reporting
  • •Use of anticoagulants or presence of coagulopathy
  • •Use of medications that may alter pain perception or rebound pain response
  • •Local infection at the block site
  • •Emergency surgeries
  • •Inability or unwillingness to complete the postoperative pain diary or follow-up

结局指标

主要结局

Incidence of Rebound Pain After Peripheral Nerve Block

时间窗: Within 48 hours after surgery

Rebound pain is defined as a sudden, severe increase in pain occurring after the resolution of peripheral nerve block, typically within 12-24 hours postoperatively. Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). A score of NRS ≥7 will be considered as severe pain. Patients will record pain scores in a pain diary, and incidence will be calculated as the proportion of patients meeting the rebound pain criteria.

次要结局

  • Sleep Quality(From 1 day before surgery to postoperative day 7)
  • Patient Satisfaction with Pain Management(Postoperative day 7 (via telephone follow-up))
  • Total Rescue Analgesic Consumption(Within 48 hours after surgery)
  • Time to First Rescue Analgesia(Within 48 hours after surgery)

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmut Sami TUTAR

Associate Professor, Department of Anesthesiology and Reanimation

Konya City Hospital

研究点 (1)

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