Effect of Rebound Pain on Chronic Postsurgical Pain After Total Knee Arthroplasty: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Presence of Chronic Postsurgical Pain at 3 Months
研究概览
简要总结
This prospective observational study aims to evaluate whether rebound pain after peripheral nerve block is associated with the development of chronic postsurgical pain following elective total knee arthroplasty. Adult patients undergoing unilateral total knee arthroplasty under spinal anesthesia and receiving a peripheral nerve block as part of routine multimodal analgesia will be included. No additional intervention, drug administration, or biological sampling will be performed beyond standard clinical care.
Rebound pain will be assessed during the early postoperative period using pain diaries, numeric rating scale pain scores, and analgesic consumption records. Chronic postsurgical pain and related outcomes will be evaluated at postoperative 3 and 6 months using validated instruments assessing pain severity, neuropathic pain features, psychological status, functional outcomes, and health-related quality of life. The primary outcome is the presence of chronic postsurgical pain at 3 months after surgery. Secondary outcomes include chronic pain at 6 months, pain intensity, neuropathic pain characteristics, opioid consumption, rescue analgesic requirements, sleep disturbance, and quality-of-life measures. The study also aims to explore demographic and clinical factors associated with rebound pain and chronic postsurgical pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •ASA physical status I to III
- •Scheduled for unilateral elective total knee arthroplasty
- •Planned to undergo spinal anesthesia
- •Planned to receive a peripheral nerve block as part of routine multimodal analgesia
- •Able to provide informed consent and complete study assessments
排除标准
- •Chronic opioid use (60 mg oral morphine equivalent per day or more, or use for 3 months or longer)
- •Significant neuropathy or radiculopathy
- •Bilateral or two-stage total knee arthroplasty during the same hospitalization
- •Contralateral total knee arthroplasty within the previous 6 months
- •Severe cognitive impairment or major psychiatric disorder
- •Chronic analgesic dependence
研究组 & 干预措施
Rebound Pain
Participants with a transition from well-controlled pain (Numeric Rating Scale [NRS] <=3) to severe pain (NRS >=7) within 0 to 48 hours after peripheral nerve block resolution.
No Rebound Pain
Participants without a transition from well-controlled pain (Numeric Rating Scale [NRS] <=3) to severe pain (NRS >=7) within 0 to 48 hours after peripheral nerve block resolution.
结局指标
主要结局
Presence of Chronic Postsurgical Pain at 3 Months
时间窗: 3 months after surgery
Chronic postsurgical pain will be defined as pain developing or persisting after total knee arthroplasty that is not explained by another cause. Participants with pain and at least one Brief Pain Inventory-Short Form interference item score of 3 or higher at postoperative month 3 will be considered positive for chronic postsurgical pain.
次要结局
- Presence of Chronic Postsurgical Pain at 6 Months(6 months after surgery)
- Pain Intensity in the Early Postoperative Period(0 to 72 hours after surgery)
- Presence of Chronic Postsurgical Pain at 6 Months assessed by Brief Pain Inventory-Short Form (BPI-SF) interference score(6 months after surgery)
研究者
Mahmut Sami TUTAR
Associate Professor, Department of Anesthesiology and Reanimation
Konya City Hospital