Effect of Local Infiltration Analgesia on Postoperative Pain Following Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale for pain
研究概览
简要总结
An anterior cruciate ligament (ACL) rupture is one of the most common sport injuries, which typically develops after a sudden knee torsion. Arthroscopic repair of the ACL is often required as a complete ACL tear can cause instability of the knee joint.
During arthroscopic reconstruction the lower leg is reattached to the upper leg using part of the hamstring tendon (mm. gracilis and mm. semitendinosus). Optimal postoperative analgesia is necessary to allow a quick recovery. Intravenous analgesia during surgery is often associated with a number of side effects such as nausea, vomiting and muscle weakness and does not anesthetize the donor site of the hamstring tendon graft. Local infiltration of ropivacaine and lidocaine in the knee joint and at the donor site can be a valuable asset to control the postoperative pain.
This study evaluates the effect of local infiltration analgesia (LIA) on the postoperative pain in the first month after an ACL reconstruction. Half of participants will only receive intravenous analgesia during surgery, the other half will receive intravenous analgesia and a LIA.
详细描述
2 x 20 patients which are planned for arthroscopic ACL reconstruction are randomised: standard-group and LIA-group.
All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics (paracetamol, diclofenac, clonidine and morfine), patients in the LIA-group receive a local infiltration in the knee of 10 mL ropivacaine and 10 mL lidocaine.
Visual Analogue Scores are assessed 15 minutes after awakening from surgery and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery. Postoperative analgesic consumption are registered in the first month after the surgery. The quality of recovery after anesthesia is assessed on Day 1 by the postoperative quality of recovery score (QoR-15).
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, Investigator, Outcomes Assessor)
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 arthroscopic anterior cruciate ligament reconstruction
排除标准
- •unwilling or unable to grant written informed consent
- •revisions
- •contra-indication for ropivacaine
研究组 & 干预措施
intravenous analgesia
Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg
intravenous analgesia + LIA
Patient receives intravenous analgesia and a local infiltration analgesia in the knee
干预措施: local infiltration analgesia (Procedure)
结局指标
主要结局
Visual Analogue Scale for pain
时间窗: From moment of surgery until one month after surgery
Pain intensity using the VAS (where 0 = no pain and 100 = pain as bad as can be) 15 minutes after awakening and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery.
次要结局
- Postoperative analgesia consumption(From moment of surgery until one month after surgery)
- General patient comfort(From moment of surgery until one day after surgery)
- Incidence of nausea and vomiting(From moment of surgery until hospital discharge (one day after surgery))
- PONV treatment(From moment of surgery until hospital discharge (one day after surgery))
研究者
Dr. Alain Kalmar, MD, PhD
Staff Anesthesist
Algemeen Ziekenhuis Maria Middelares