Pre-operative Intravenous Steroid in Unilateral Primary Total Knee Replacement for Pain Relief and Recovery: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain from operated knee using 100mm visual analogue scale
研究概览
简要总结
Osteoarthritis of the knee is a common and important condition in our society. Despite various anesthetic methods and pain medications, pain after operation still remains as a challenge.
Steroids plays a role in decreasing the inflammatory reaction and stress response from surgery.
This study is to evaluate the use of an additional steroid injection, on top of usual pain killers and anesthesia, on the effect of pain control and recovery after total knee replacement.
50 subjects will be recruited, half of them will be randomized to receive a single dose of steroid injection before operation while the other half will receive a placebo. All the doctors, patients and physiotherapists are not aware of the allocation. Apart from the steroid or placebo injection, all the other treatment (eg: surgery, medications, rehabilitation protocol etc) will be the same. Doctors and physiotherapists will assess the subjects at 24, 30, 48 hours after surgery and upon discharge for their pain relief and recovery. Any complications will also be documented.
详细描述
Osteoarthritis of the knee is a common and important disease in the population. As a joint replacement centre, around 600 total knee replacements were performed in Queen Elizabeth Hospital and Buddhist Hospital per year. Despite multiple anesthetic methods and analgesics protocols, post-operative pain remains a significant problem.
Perioperative use of steroids has been shown to reduce postoperative nausea and vomiting. In both orthopaedic and non-orthopaedic operations, a single high dose of pre-operative steroid was also found to be effective in reducing early postoperative pain.
The hypothesis is that steroids help reduce post-operative inflammation and surgical stress response. Inflammatory markers such as IL-6 and C-reactive protein showed significant reduction after administration of perioperative steroids.
In a Denmark randomized-controlled trial published in 2010, the authors found that a single high-dose of methylprednisolone significantly reduce post-operative pain upto 48 hours in patients undergoing unilateral primary total knee replacement. Another randomized-controlled trial conducted in Korea in 2013 also showed significant pain control with less opioid consumption 6-24 hours after total knee replacement using dexamethasone. A group of United States researchers demonstrated that 3 doses of perioperative low dose hydrocortisone could also reduce post-bilateral total knee replacement pain at 24 hours with significant greater range of motion in a randomized-controlled trial published in 2012. However, there is no data on the effect of perioperative steroid use in Chinese population receiving total knee arthroplasty.
Upon induction, the intervention group will receive 125mg methylprednisolone diluted in 2.1ml of diluent intravenously. The placebo group will receive 2.1ml of 0.9% intravenous saline, which is transparent and has no difference in appearance to methylprednisolone.
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
Patients receiving elective unilateral primary total knee replacement in Queen Elizabeth Hospital during May 2017 to October 2017 will be assessed for eligibility according to the inclusion and exclusion criteria. 50 subjects will be recruited and randomized using computer into intervention group and placebo group by a nurse otherwise not involved in the trial. The randomization will be concealed in an opaque envelope.
On the day of operation, a surgeon otherwise not involved in the trial will prepare the methylprednisolone and saline (placebo). The envelope will be opened by the list anesthetist. The operating surgeons, anesthetists, assessors (physiotherapists) and the patients were all blinded to the allocation.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective unilateral total knee replacement for primary osteoarthritis of knee
- •ASA (American Society of Anesthesiologists) grading 1 or 2
排除标准
- •Rheumatoid arthritis or seronegative arthritis
- •Allergy to any medications used in the standard protocol (Methylprednisolone, adrenaline, ropivacaine, ketorolac, bupivacaine, ketorolac, pepcidine, transamin, gabapentin, voltaren, panadol, DF118)
- •Chronic opioid use
- •Substance dependence
- •Patients attending chronic pain clinic
- •Psychiatric or neurological condition that may influence pain perception or reporting
- •Chronic illness that preclude the use of the medications in the standard protocol
- •Hepatitis B carrier or Elevated bilirubin or ALT
- •Active peptic ulcer disease
- •Uncontrolled diabetic patients with HbA1c >7% in recent 3 months
研究组 & 干预措施
Methylprednisolone Group
The intervention group will receive a single dose intravenous 125mg methylprednisolone diluted in 2.1ml of diluent on induction of total knee replacement.
干预措施: Methylprednisolone Sodium Succinate (Drug)
Placebo Group
The placebo group will receive a single dose intravenous 2.1ml of 0.9% IV saline, which is transparent and has no difference in appearance to methylprednisolone, on induction of total knee replacement
干预措施: Placebos (Drug)
结局指标
主要结局
Pain from operated knee using 100mm visual analogue scale
时间窗: 24 hours after surgery
during walking 5 metres with frame, using 100mm visual analogue scale
次要结局
- C-reactive Protein(day 1 after surgery)
- Pain from operated knee (other than primary outcome) using 100mm visual analogue scale(24 hours after surgery)
- Length of stay(upon discharge usually around post operative day 7)
- Sleep quality using 0-100 visual analogue scale(day 1 after surgery)
- Rescue analgesics consumption(upon discharge usually around post operative day 7)
- Pain from operated knee using 100mm visual analogue scale(upon discharge usually around post operative day 7)
- Range of movement from operated knee(24, 30, 48 hours after surgery, upon discharge usually around post operative day 7)
- Patient-controlled analgesia consumption(48 hours after surgery)
- Time to achieve independent frame walking(upon discharge usually around post operative day 7)
- Knee circumference of the operated knee(48 hours after surgery)
研究者
Cheng Lok Yiu
Resident
Queen Elizabeth Hospital, Hong Kong