Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis - A Randomized Controlled Trial Clinical Study Protocol
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale
研究概览
简要总结
We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who are undergoing Total Knee Arthroplasty to understand which of the three treatments give more benefits to the patient.
详细描述
A total of 159 patients will be needed (53 patients per arm, 3 arms in total). Dexamethasone (brand name: Mephameson) is the steroid drug that we perioperative administer in two different ways: intra-venous (IV) dexamethasone (9mg) in arm-A, intra-articular (IA) dexamethasone (9mg) in arm-B. No steroid supplementation will be provided in the control group (arm-C).
The primary objective of the study is to compare the effect on post-operative pain of I.V. and I.A. perioperative dexamethasone supplementation for total knee arthroplasty (TKA).
The secondary objectives of the studies will be the comparison between I.V. and I.A. peri-operative dexamethasone supplementation in terms of post-operative pain and function, opioids and analgesic drugs consumption, knee range of motion, systemic inflammatory response, time to mobilisation, length of stay, and patient satisfaction.
Moreover, both I.V. and I.A. steroid supplementation protocols will be compared to routine analgesia protocol (no steroid supplementation group) in order to document their advantages over the absence of steroid supplementation.
The safety of I.V. and I.A. peri-operative dexamethasone will be evaluated and compared recording all the steroid supplementation related complications. In particular, the risk of hyperglycaemia-related complications and post-operative infections will be documented. The safety of both I.V. and I.A. steroid supplementation protocols will be verified comparing them to the no-treatment group in terms of incidence of complications.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The present study will be double blinded: both participants and assessor will be blinded to the assigned treatment. Only the surgeons and the anaesthetists taking part to surgery will be aware of the group to which the patient was assigned but they will not take part to the follow-up visits.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano.
- •Patients with a BMI >18.5 and <
- •Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
- •Informed Consent as documented by signature (Appendix Informed Consent Form).
排除标准
- •Contraindications to steroids.
- •Revision TKA.
- •Active steroid therapy.
- •Women who are pregnant or breast feeding.
- •Presence of other clinically significant concomitant disease states (ASA IV).
- •Uncontrolled diabetes mellitus
- •Known or suspected non-compliance, drug or alcohol abuse.
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
- •Previous enrolment into the current study.
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
研究组 & 干预措施
arm-A Intra-venous dexamethasone
9 mg of Intra-venous dexamethasone
干预措施: Dexamethasone Sodium Phosphate 4 mg/ml intravenous (Drug)
arm-B intra-articular dexamethasone
9 mg of intra-articular dexamethasone
干预措施: Dexamethasone Sodium Phosphate 4 mg/ml intra-articular (Drug)
arm-C routine
No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group
结局指标
主要结局
Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale
时间窗: 3 days after surgery
Mean daily pain at rest during the first 3 days reported on a 0-10 numeric rating scale (NRS) by the patients. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.
次要结局
- Post-operative knee pain during the first 10 years after surgery(10 years)
- Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC)(10 years)
- Knee conditions on Knee society score (KSS)(10 years)
- Quality of pain on PainDETECT questionnaire(10 years)
- Post-operative nausea intensity(During Hospitalization, approximately 3 days)
- Time needed for climbing stairs the first time(approximately 1 week)
- Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale(6 weeks after surgery)
- Patient satisfaction: numeric rating scale (NRS)(10 years)
- Post-operative function during the first 6 weeks after surgery(6 weeks)
- Post-operative knee function during the first 10 years after surgery(10 years)
- Post-operative opioids and analgesic drugs consumption(During Hospitalization, approximately 3 days)
- Post-operative C-Reactive Protein (CRP)(every days 3 days from surgery)
- Time from surgery to first mobilization(During Hospitalization, approximately 1 days)
- Length of hospital stay(approximately 1 week)
- Post-operative nausea incidence(During Hospitalization, approximately 3 days)
- Post-operative erythrocyte sedimentation rate (ESR)(every days 3 days from surgery)
研究者
Christian Candrian
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona