A Comparison of the Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
试验速览
- 阶段
- 4 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement
研究概览
简要总结
Total knee replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.
We further hypothesize that the use of this surgical site infiltration technique would decrease post-operative systemic opioid requirements as well as the side effects associated with intrathecal and systemic opioids.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for unilateral total knee replacement
- •Consent to spinal anaesthesia
- •ASA Grade I to III
排除标准
- •Patient refusal
- •Mini-Mental Score < 25 (see appendix 3)
- •Allergy to bupivacaine, morphine, paracetamol, diclofenac
- •Skin lesions/infection at site of injection
- •Uncorrected renal dysfunction
- •Coagulation disorders
- •chronic pain condition other than knee pain
研究组 & 干预措施
levobupivacaine infiltration
Patients will receive spinal anaesthesia with intrathecal bupivacaine (17.5 or 15 mg) without morphine, and will receive peri- and intraarticular surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% at 8am the following morning.
干预措施: Levobupivacaine (Drug)
Control
Patients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg).
干预措施: Intrathecal morphine (Drug)
结局指标
主要结局
Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement
时间窗: 24 hours postoperatively
次要结局
- Opioid consumption in total in the first 48 hours postoperatively(48 hours postoperatively)