Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?
试验速览
- 阶段
- 2 期
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
研究概览
简要总结
This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.
详细描述
The addition of dexamethasone to an local infiltration analgesia (LIA) mixture for postoperative analgesia following total knee arthroplasty (TKA) has a limited evidence base. Although there is increasing support in the literature for its use in peripheral nerve blockade, there have only been a handful of studies assessing its applicability in periarticular LIA. Moreover, the evidence from peripheral nerve blocks suggests that one of the key benefits of dexamethasone is a prolongation of nerve blockade. Additionally, dexamethasone has been shown to prolong the local analgesic effect of bupivacaine microcapsules.
With respect to total hip arthroplasty (THA), there have only been two small studies that included corticosteroids in the LIA mixture; there was analgesic benefit and better early rehabilitation outcomes when compared to placebo. However, there is limited high-quality evidence for either THA or TKA demonstrating an improvement in functional outcomes when dexamethasone is used in an LIA mixture. This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Undergoing elective, primary, unilateral total hip or knee arthroplasty under spinal anesthesia
- •ASA-PS I-III
- •18-85 years of age, inclusive
- •50-100 kg, inclusive
- •BMI 18 - 40
排除标准
- •Revision hip/knee arthroplasty
- •Bilateral hip/knee arthroplasty
- •Inability or refusal to provide informed consent
- •Any contraindication to spinal anesthesia (e.g., bleeding diathesis, infection, neuropathy)
- •Allergy to local anesthesia, ketorolac or dexamethasone
- •Allergy to opioids
- •Chronic pain state, neuropathic pain
- •Opioid dependence
- •Diabetic patients will NOT be excluded except those with significant peripheral neuropathy
研究组 & 干预措施
Dexamethasone
LIA mixture with the addition of 8mg Dexamethasone.
干预措施: Dexamethasone (Drug)
Dexamethasone
LIA mixture with the addition of 8mg Dexamethasone.
干预措施: LIA Combination Mixture (Drug)
Saline
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
干预措施: 0.9% NaCl Placebo (Other)
Saline
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
干预措施: LIA Combination Mixture (Drug)
结局指标
主要结局
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
时间窗: 3 days - post operative
次要结局
- Analgesic outcomes- pain(3 days - post operative)
- Analgesic outcomes- opiate consumption(3 days - post operative)
- Analgesic outcomes- TUG test(3 days - post operative)
- Analgesic outcomes- Drug side-effects(3 days - post operative)
- Short-term physical and performance-based functional outcome measures- in hospital complications(3 days post operative)
- Short-term physical and performance-based functional outcome measures- length of stay(3 days - post operative)
- Short-term physical and performance-based functional outcome measures- discharge(3 days - post operatively)
- Medium-term self-reported functional outcome measures- WOMAC(3 months- post operative)
- Medium-term self-reported functional outcome measures- LFES(3 months- post operative)