Effects of Preoperative Dexamethasone in Post-operative Pain Control After Total Knee Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
The primary aims of total knee replacement are improvement in functional activities and reduce pain due to degenerated knee joints. However, there are around 20-30% of patients would develop significant pain problem despite uncomplicated total knee replacement. It accounts for major post-operative problems and burdens.
Dexamethasone is glucocorticoid which is associated with anti-inflammatory response. It is well known to have prophylaxis effect for post-operative nausea and vomiting. Perioperative single dose of systemic dexamethasone have shown to be useful for reduction in pain and cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after surgical procedures. However, this dose recommendation is not surgery specific. It is essential to have more RCTs evaluating the optimal dose of steroid for pain management after hip and knee surgery.
详细描述
Patients will be approached at the preadmission clinic or in the general ward before operation. The analgesic methods will be explained and s/he will be recruited into the study if s/he agrees. There are standardized preoperative, intraoperative and postoperative analgesic regimes for patients undergoing total knee replacement.
For preoperative analgesic regime, pregabalin 50mg are given the night before operation. Same analgesic regime is used on the day before operation. For intraoperative regime, standardized intraarticular local anaesthetic infiltration is used. For postoperative analgesic regime, PCA using morphine is used. In addition to PCA using morphine, standardized analgesic regime is used -- regular pregabalin 50mg nocte, paracetmal 1g QID, Celebrex 200mg BD will be given for 5 days.
Patients will be randomized into one of three groups. Patients in the first group (D1) will receive standardized oral analgesic regime pre-operatively, intraoperatively and postoperatively. In addition to the above, they will be given preoperative intravenous 8mg dexamethasone. Patients in the second (D2) group will be given preoperative intravenous 16mg dexamethasone, in addition to same pre-operative, intraoperative and post-operative analgesic regimes. Patients in the third (C) group will be given preoperative intravenous 4ml 0.9% saline, in addition to same pre-operative, intraoperative and post-operative analgesic regimes.
Preoperative Care Assessment will be done at the preadmission clinic or at the general ward. Pre-operative pregabalin will be given before operation and on the day before operation. Fasting will start six hours before operation.
Range of movement of the operating knee, quadriceps function, pain scores of the affecting knee will be assessed on day before operation.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Age 18-80 years old
- •Scheduled for elective primary unilateral total knee replacement
- •Chinese patients
- •Able to speak and understand Cantonese
- •Able to provide informed oral and written consent
排除标准
- •Revision total knee replacement
- •Single stage bilateral total knee replacement
- •Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
- •History of chronic pain other than chronic knee pain
- •History of insulin dependent diabetic mellitus, but not diabetic mellitus on oral hyperglycaemic agents
- •History of hepatitis B or C carrier
- •History of peptic ulcer
- •Hx of tuberculosis
- •History of immunosuppression
- •Daily use of glucocorticoids
- •Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
- •History of severe heart disease (NYHA 2)
- •Alcohol or drug abuse
- •Impaired renal function, defined as preoperative serum creatinine level over 120micromol/L
- •Pre-existing neurological or muscular disorders
- •Psychiatric illness or neurologic or psychiatric diseases potentially influencing pain perception
- •Impaired or retarded mental state
- •Difficulties in using patient controlled analgesia (PCA)
- •Pregnancy
- •Local infection
- •On immunosuppresants
- •Patient refusal
研究组 & 干预措施
Group D1
Patients from group D will be given a bolus injection of 2 ml saline with 2 ml dexamethasone (4mg/ml) before skin incision.
干预措施: Dexamethasone (Drug)
Group D2
4ml bolus injection of dexamethasone (4mg/ml) will be given intravenously prior to incision.
干预措施: Dexamethasone (Drug)
Group C
4ml bolus injection of 0.9% saline will be given intravenously prior to incision
干预措施: Saline (Drug)
结局指标
主要结局
pain score
时间窗: at postoperative day 1
Pain will be measured using numerical rating scale from 0 to 10 with 0 is no pain and 10 is the worst pain
次要结局
- quality of recovery(at postoperative day 1)
研究者
Dr. Chi-Wai Cheung
Clinical Associate Professor
The University of Hong Kong