Local Continuous Wound Infusion and Local Infusion of Anaesthetics in the Management of Post-operative Pain and Rehabilitation After Total Hip Arthroplasty: a Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 96
- 主要终点
- Incident and rest pain (using VAS score) at 72 hours after surgery
研究概览
简要总结
The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents
详细描述
Wound infiltration with local anesthetics is an analgesic technique that has been adopted for post-operative analgesia following a range of surgical orthopaedic procedures. Pain management by infusion of local aesthetic into wounds was found to improve pain, reduced opioid use and side effects, increase patient satisfaction, and shorten the hospital stay when compared to placebo or no treatment, but actually it was not definitively proven that wound infiltration provides additional analgesic or outcome benefit in the setting of a comprehensive multimodal analgesic approach. The hypothesis of this study is that a consistent amount of Levobupivacaine 0.5% for LCWI and LIA could provide a more extended postoperative analgesia for post-operative incident and rest pain with a better post-operative recovery and rehabilitation following THA, in the first 72 hours after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-90 years of age
- •American Society of Anaesthesiologists (ASA) physical status I-III
- •total hip arthroplasty.
排除标准
- •pregnancy
- •body mass index (BMI) >35
- •allergy to local anaesthetics
- •skeletal and/or muscle abnormalities of the spine
- •primary and/or secondary neurological diseases
- •psychiatric diseases
- •history of chronic pain and/or neuropathic disorders
- •history of drug abuse
- •state of sepsis
- •infection and/or tumours within the skin on the back
- •primary or secondary coagulopathies
- •primary or secondary heart, liver and renal failure.
研究组 & 干预措施
Levobupivacaine infusion
1500 mg of Levobupivacaine by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected.
干预措施: Levobupivacaine (Drug)
Saline infusion
300 ml of Saline (for Levobupivacaine as placebo) by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected.
干预措施: Saline (Drug)
结局指标
主要结局
Incident and rest pain (using VAS score) at 72 hours after surgery
时间窗: 72 hours
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
次要结局
- Consumption of painkillers (in mg) at 72 hours after surgery(72 hours)
- Side effects (PONV) at 72 hours after surgery(72 hours)
- Wound healing at 72 hours(72 hours)
- Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery(72 hours)
- Improvement of rehabilitation at 72 hours(72 hours)
研究者
Emiliano Petrucci
Anesthesist
San Salvatore Hospital of L'Aquila