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临床试验/NCT05510947
NCT05510947已完成不适用

Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty - A Prospective, Observational, Single-center, Cohort Study

Copenhagen University Hospital, Hvidovre1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
146
试验地点
1
主要终点
Ratio between HPR:LPR patients defined as patients with PCS > 20 and PCS ≤ 20 respectively

研究概览

简要总结

Advantages of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) include shorter hospital stays, faster recovery, fewer infections and readmission, and lower costs. It is well documented in TKA-surgery that high pain responders (HPR), evaluated using the Pain Catastrophizing Scale (PCS), have higher postoperative pain responses compared to low pain responders (LPR). These HPR-patients constitute a vulnerable high risk patient group and potentially benefit from targeted treatment. Currently, the distribution of HPR- and LPR-patients and their association with acute pain following UKA is not well investigated. The knowledge that this research project generates is essential to determine how studies with analgesia interventions should be designed. In the future this will contribute in targeting treatment for high risk patient groups to reduce pain and improve postoperative mobilization, and ultimately decrease length of hospital stay in patients undergoing UKA. By targeting treatment, a potential overtreatment is also avoided.

The aim of this study is to investigate the prevalence of high- and low-pain responders, defined by a PCS score > 20 and ≤ 20 respectively, as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty.

详细描述

Background:

Primary knee arthroplasty is a frequently performed procedure and is expected to increase in numbers over the next decade. Advantages of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) include shorter hospital stays, faster recovery, fewer infections and readmissions, and lower costs. The length of hospital stay after UKA is variable, but an increased length of hospitalization has been associated with more complications and higher readmission rates. A recent study has shown that the main reasons for continued hospitalization beyond 24 hours after surgery are pain and lack of mobilization. Strategies to decrease the length of stay after UKA should thus be aimed at improved analgesia and postoperative mobilization.

There is a large interindividual variability in the postoperative pain response. It is well documented in TKA-surgery that high pain responders (HPR), evaluated using the Pain Catastrophizing Scale (PCS), have higher postoperative pain responses compared to low pain responders (LPR). Recently, it has been shown that HPR patients undergoing TKA benefit from a larger preoperative dose of glucocorticoid compared to a previously recommended dose. Interestingly, the same difference has not been found in LPR patients (Nielsen et al.: IN PREPARATION, clinicaltrials.gov ID NCT03758170, EudraCT 2018-002634-20, VEK H-18034756). These HPR patients constitute a vulnerable high-risk patient group and potentially benefit from targeted treatment.

Currently, the distribution of HPR- and LPR patients and their association with acute pain following UKA is not well investigated. The generated knowledge from this research project is essential to determine how studies with analgesia interventions should be designed. In the future, this will contribute to targeting treatment for high-risk patient groups to reduce pain and improve postoperative mobilization, and ultimately decrease the length of hospital stay in patients undergoing UKA. By targeting treatment, a potential overtreatment is also avoided.

Aim:

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

入选标准

  • Primary unilateral UKA
  • Age ≥ 18 years
  • Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
  • Filled out the Pain Catastrophizing Scale preoperatively.
  • Signed written informed consent form.

排除标准

  • Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
  • Insulin-treated diabetes mellitus
  • Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
  • Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
  • Peripheral nerve block per- or postoperatively.

结局指标

主要结局

Ratio between HPR:LPR patients defined as patients with PCS > 20 and PCS ≤ 20 respectively

时间窗: Preoperatively

次要结局

  • Incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively in LPR patients(24 hours)
  • Incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively in HPR patients(24 hours)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Deichmann Springborg

MD, PhD-student

Copenhagen University Hospital, Hvidovre

研究点 (1)

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