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临床试验/NCT07378215
NCT07378215尚未招募4 期

The Effect of Corticosteroids on Quality of Life Following Total Hip Arthroplasty: HIPSTER Study

Ziekenhuis Oost-Limburg1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
224
试验地点
1
主要终点
Health-related quality of life (EQ5D5L)

研究概览

简要总结

Total hip arthroplasty (THA) is a highly effective and commonly performed procedure for end-stage osteoarthritis. Perioperative inflammation contributes to postoperative pain, fatigue, and delayed recovery. Dexamethasone, a potent glucocorticoid with strong anti-inflammatory properties, is widely used in orthopedic surgery and incorporated into Enhanced Recovery After Surgery (ERAS) protocols for THA to reduce pain, PONV, and fatigue. While intermediate doses of dexamethasone (25 mg) are considered safe and beneficial in the short term, their long-term effects on health-related quality of life and persistent pain remain unclear.

Therefore, the main objective of the HIPSTER trial is to evaluate the effect of different doses of a single intraoperative intravenous dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery.

详细描述

Total hip arthroplasty (THA) is a successful and cost-effective treatment for end-stage osteoarthritis and other degenerative hip conditions. It is one of the most frequently performed surgical procedures worldwide and continues to increase in volume each year, largely due to the growing population of older adults. Despite its effectiveness, THA is associated with significant surgical trauma that induces a pronounced inflammatory response, leading to postoperative pain, fatigue, postoperative nausea and vomiting (PONV), prolonged hospital stays, and delayed functional recovery. Prevention of postoperative inflammation can be a crucial cornerstone to optimize recovery and enhance outcomes after THA.

Dexamethasone, a potent and long-acting glucocorticoid with strong anti-inflammatory properties, is widely used in orthopedic surgery. It suppresses prostaglandin synthesis by downregulating cyclooxygenase-2 expression, thereby inhibiting cell adhesion factor expression and cytokine gene transcription. Dexamethasone also reduces neutrophil and macrophage exudation and activity at inflammatory sites, decreasing cellular adhesion and aggregation along vascular endothelium. Although dexamethasone has a short half-life of approximately 36-72 hours, by modulating the surgical stress response and its multiple downstream effects on inflammation, acute pain, nausea, and fatigue, it may also influence longer-term outcomes. Due to these mechanisms, dexamethasone has become an integral component of perioperative management in various surgical disciplines, including THA.

Previous studies have demonstrated that perioperative dexamethasone administration can attenuate inflammatory responses, reduce PONV, and acute postoperative pain and fatigue in patients undergoing THA. These short-term benefits translate into improved early postoperative recovery, which can be quantified using validated instruments such as the Quality of Recovery-15 (QoR-15) score. Consequently, dexamethasone is now commonly incorporated into Enhanced Recovery After Surgery (ERAS) protocols for THA. Intermediate glucocorticoid doses - equivalent to 25 mg of dexamethasone - are generally considered safe and are part of the standard of care in many arthroplasty centers performing primary THA.

While the short-term benefits of dexamethasone on postoperative inflammation, acute pain control, PONV reduction, early recovery, and hospital length of stay are well established in THA, concerns remain regarding its long-term safety profile. Several studies have reported potential adverse effects associated with intermediate to high doses, such as impaired sleep quality, immunosuppression, and possible wound-healing complications. Although glucocorticoids at the implemented doses have demonstrated efficacy in reducing acute postoperative pain, their role in preventing chronic postsurgical pain (CPSP) remains unclear, with some studies suggesting even a trend to persistent wound pain with higher doses of dexamethasone. Furthermore, the long-term effects of perioperative dexamethasone on health-related quality of life (HRQoL) following THA have not yet been systematically investigated.

As health-related quality of life, assessed by EQ-5D, is an important patient-reported outcome following anaesthesia and surgery, as emphasised in the StEP-COMPAC initiative, the effect of different doses of dexamethasone on health-related quality of life needs further investigation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 60 years or older;
  • scheduled for elective total hip arthroplasty;
  • procedure under spinal anaesthesia.

排除标准

  • hip revision surgery (reoperation);
  • bilateral total hip arthroplasty during the same procedure;
  • known hypersensitivity to dexamethasone or other corticosteroids;
  • chronic systemic use of corticosteroids, defined as daily corticosteroid therapy for > 4 weeks within the last 3 months, with anticipated need for a perioperative stress dose of corticosteroids;
  • active gastric of intestinal ulcers;
  • lack of informed consent or inability to give informed consent;
  • urgent, non-elective surgery.

研究组 & 干预措施

Intervention group 1

Active Comparator

A single intraoperative dose of intravenous dexamethasone 5 mg

干预措施: Dexamethasone (IV) (Drug)

Intervention group 2

Active Comparator

A single intraoperative dose of intravenous dexamethasone 25 mg

干预措施: Dexamethasone (IV) (Drug)

结局指标

主要结局

Health-related quality of life (EQ5D5L)

时间窗: Preoperative and postoperative day 30, day 60 and day 90

The EQ5D is used for measuring health-related quality of life. EQ5D5L provides a single index value for health status which can be used to assess overall health. The descriptive profile consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems, or not able. Respondents select the level that best describes their current health status. The questionnaire will be taken preoperatively, on day 30, day 60 and day 90 following surgery.

次要结局

  • Quality of Recovery (QoR)(Preoperative and postoperative day 1, day 3 and day 5)
  • Health-related quality of life (EQ-VAS)(Preoperative and postoperative day 30, day 60 and day 90)
  • Oxford Hip Score (OHS)(Postoperative day 30, day 60 and day 90)
  • Brief Pain Inventory (BPI)(Preoperative and postoperative day 30, day 60 and day 90)
  • Chalder fatigue questionnaire (CFQ)(Preoperative and postoperative day 30, day 60 and day 90)

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Sponsor

研究点 (1)

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