Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response - A Randomized Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Postoperative pain after 48 hours / day 2 morning, according to VAS-scale
研究概览
简要总结
The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty (TKA) in an High Pain Respondes (HPR) population to a standard single high dose systemic preoperative administration in an HPR population.
As a standard procedure, all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale (PCS). If TKA is decided, patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mg/kg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA.
The repeat-dosing group (RDG) will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day. The control-group (CG) will receive placebo tablets at 9-11 pm on the first postoperative day.
详细描述
Total hip and knee arthroplasty (THA/TKA) are frequently performed procedures and are expected to increase in numbers along with the growing elderly population the next decade.
Total Knee Arthroplasty (TKA) is suitable for FAST-TRACK surgery, and is often performed as outpatient surgery with no hospital overnight stay.
Challenges in FAST-TRACK surgery include postoperative pain, nausea and vomiting (PONV), complications due to rescue-analgesics and surgical complications.
Pain is a well-known clinical problem, with up to 75% of TKA patients experiencing moderate to severe pain the first day after surgery, and 30-40% still experiencing moderate to severe pain 2 weeks after surgery, potentially delaying ambulation and recovery within the first weeks.
The role of severe acute postoperative pain upon the development of chronic pain is debatable, but important.
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)
盲法说明
Blinding The patient, all personnel attending in treatment and care of the patient, the investigators and the sponsor will all be blinded to the study-drug allocation, until all data processing is finished.
The randomization-sequence will be stored in a sealed envelope at the Pharmacy at Lillebaelt Hospital who carried out the packaging-process. The randomization personnel have no contact to the patient.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years.
- •Primary unilateral TKA.
- •Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
- •Signed written informed consent form.
- •Moderate to severe postoperative pain (VAS >30) in a 5-meter walk test 22-26 hours after end of surgery.
排除标准
- •Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids.
- •Insulin-dependent diabetes.
- •Pregnancy or breastfeeding.*
- •Allergies concerning the study-drug.
- •Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
- •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.
- •Pregnancy: No women with suspected or proven pregnancy are eligible for inclusion. The following will be considered as safe contraception: intrauterine device or hormonal contraception. For women aged between 40-50 years, a urine HCG test for pregnancy will be performed.
研究组 & 干预措施
Placebo tablet on day 1 after surgery given as one single dose.
Control Group (CG):
Intervention: Postoperative oral placebo tablet on day 1 after surgery given as one single dose.
干预措施: Placebo (Drug)
Dexamethasone 24 mg on day 1 after surgery given as one single dose.
Repeat Dose Group (RDG):
Intervention: Postoperative oral dexamethasone 24 mg on day 1 after surgery given as one single dose.
干预措施: Dexamethasone 24 mg (Drug)
结局指标
主要结局
Postoperative pain after 48 hours / day 2 morning, according to VAS-scale
时间窗: Day 2 morning
The amount of patients with moderate postoperative pain in a 5 meter walk test day 2 morgning(48 hours) postoperatively after total knee-arthroplasty. Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS \>30 mm.
次要结局
- Patient satisfaction with analgesic regimen in a ordinal scale from 0 to 10(Day 7)
- Number of re-admissions within 30 days, and reasons why (follow-up by EPJ on postoperative day 30)(Day 30)
- Morbidity and mortality (30-day follow-up by EPJ or telephone).(Day 30)
- Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward(Day 7)
- Cumulated pain upon ambulation, according to VAS-scale (0-100mm), in a 5-meter walk test(From day 2-3)
- Cumulated pain score, according to VAS-scale (0-100mm), at rest, upon ambulation in a 5-meter walk test and at night according to VAS-scale(0-100mm)(From day 2-7)
- Quality of sleep, lethargy, dizziness, and nausea postoperative registration, according to the VAS-scale(0-100mm)(From day 2-7)
- Cumulative use of rescue analgesics per day.(From day 2-7)