Effect of a Single Shot Sciatic Nerve Block (SNB) Combined With a Continuous Femoral Block (CFNB) on Pain Scores After Knee Arthroplasty. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)
研究概览
简要总结
The purpose of this study is to determine if the addition of a sciatic nerve block (SNB) to a continuous femoral nerve block (CFNB) improves post-operative analgesia after knee arthroplasty.
详细描述
Background: Postoperative pain after total knee replacement /arthroplasty (TKA) is a major concern. It is severe pain in 60% of patients and moderate in 30%. Continuous femoral nerve blocks (CFNB) are considered an excellent choice for regional anesthesia for major knee repair but there are some controversies about the need of supplemental obturator or sciatic nerve blocks for achieving better postoperative analgesia. A recent meta-analysis states there is no sufficient evidence to recommend or discharge these associations.
Objectives: We aim to assess the efficacy of the association of a sciatic nerve block (SNB) and a continuous femoral nerve block (CFNB) for reducing postoperative pain in patients submitted to TKA. Methods: A randomized controlled study on 50 patients submitted to TKA. Control group receives a femoral nerve block with a catheter before general anesthesia is induced and the intervention group gets a similar block plus a single shot SNB before general anesthesia. Both groups start a continuous local anesthetic infusion through femoral catheter after the end of surgery and supplemental oral diclofenac and paracetamol. Pain scores are measured until 24h postoperatively, side effects and patient satisfaction are monitored.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral total knee replacement
排除标准
- •Contra-indication for general anesthesia
- •Infection on puncture site
- •Coagulation disorders
- •Pre-existent neuropathies
- •Allergies to local anesthetics, paracetamol, diclofenac and tramadol
- •Severe dyspepsia
- •Less than 50kg weigh
- •Body Mass Index (BMI) greater than 40
- •American Society of Anesthesiologists (ASA) Physical Status 4 or 5
- •Absence of capacity to use the Visual Analog Score (VAS) scale
- •Refusal to give informed consent
结局指标
主要结局
Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)
时间窗: 15-30 min after arrival on post anesthesia care unit (PACU)
Pain scores measured by Visual Analogue Score (VAS) scale at 15-30min after Post anesthesia care unit (PACU) arrival VAS is a 100mm scale to measure pain. 0mm - no pain 100mm - worst possible pain
VAS Results - Pain Measured in mm (0-100)
时间窗: 12h after surgery
VAS pain scores are measured by blinded investigators 12h after surgery . VAS scale: 0 - no pain 100 - worst possible pain
VAS Results - Pain Scores Measured in mm (0-100)
时间窗: 24h after surgery
VAS pain scores are measured by blinded investigators 24h after surgery . VAS scale: 0 - no pain 100 - worst possible pain
次要结局
- Satisfaction With Anesthesia Technique in Each Arm of the Study(1 month after surgery)
研究者
Raul Carvalho
Anesthesiology Consultant
Centro Hospitalar do Porto