Added Value of Systemic Lidocaine in Combination With Local Infiltration Analgesia for Knee Arthroscopic Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Score for pain
研究概览
简要总结
Local intra-articular injection of anesthetics (LIA) is increasingly used during knee arthroscopy for pain relief. The LIA can only be performed at the end of surgery as the knee joint is continuously flushed during the arthroscopy. As a consequence, an optimal analgesic effect is only obtained one hour after surgery and opiates are typically used as pain relief in the immediate postoperative period. Since these opiates have a number of side effects such as nausea, vomiting and drowsiness, other analgetic methods are desirable.
Intravenous administration of lidocaine, a safe, inexpensive analgesic, is already used in major (abdominal) surgeries and might also be a promising method for pain relief in the first hour after knee arthroscopy, in anticipation of the onset of the analgesic effect of the LIA.
The aim of this study is to verify if systemic administration of lidocaine has a beneficial effect on the pain immediately after knee arthroscopy. In addition, the effect of systemic lidocaine administration on postoperative nausea, vomiting and general patient comfort will be evaluated.
详细描述
2X30 patients which are planned for elective knee arthroscopy are randomised: Lidocaine-group and Placebo-group.
All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics paracetamol & diclofenac, the patient is administered either linisol 2% (1.5 mg/kg) or placebo NaCl 0.9% (0.075 ml/kg = equivalent volume). At the end of the procedure, linisol or placebo is readministered at the same dose. The surgeon and anesthesiologist are blinded for patient allocation.
Postoperative analgesic consumption, nausea and vomiting (PONV), general comfort and pain scores are recorded. Visual Analogue scores (VAS) for knee pain are assessed before surgery, 1-15 minutes after awakening, at the moment of discharge from the post-anesthesia care unit (PACU) and at hospital discharge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The medicine used for each individual patient will be prepared by the nurse not otherwise involved in patient data collection.
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
- •signed informed consent
- •patients which are planned for elective knee arthroscopy
- •ASA 1 and 2
- •knee arthroscopy suitable for intra-articular injection of anesthetics
排除标准
- •contra-indication for lidocaine, paracetamol or diclofenac
- •known history of severe post-operative nausea or vomiting
- •knee arthroscopy associated with anterior cruciate ligament reconstruction
研究组 & 干预措施
systemic lidocaine
Lidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery.
干预措施: systemic lidocaine (Drug)
Placebo
Saline 0.9% IV bolus: 0.075 ml/kg at induction of anesthesia and at the end of surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analog Score for pain
时间窗: from moment of surgery until hospital discharge. on average 8 hours after surgery
Pain intensity using the VAS, where 0 = no pain and 100 = pain as bad as can be) before surgery, 1-15 minutes after awakening, at discharge from the PACU and from the hospital
次要结局
- incidence of Nausea and vomiting(from moment of surgery until hospital discharge. on average 8 hours after surgery)
- PONV treatment(from moment of surgery until hospital discharge. on average 8 hours after surgery)
- opioid use(at the PACU on average 60 minutes)
- length of stay at the PACU(from moment of surgery until discharge from the PACU. on average 60 minutes after surgery)
- general patient comfort(at the moment before of hospital discharge. on average 8 hours after surgery.)
研究者
Dr. Alain Kalmar, MD, PhD
Staff Anesthesist
Algemeen Ziekenhuis Maria Middelares