Randomized, Controlled Trial of Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale
研究概览
简要总结
Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected lidocaine prior to regional and general anesthesia.
详细描述
The J-tip device has not been reported for use prior to regional block anesthesia prior to femoral or sciatic nerve blocks. The use of the J-tip device for lidocaine introduction prior to femoral or sciatic blocks at Arnold Palmer Medical Center has been up to the discretion of the anesthesiologist. It has been anecdotally reported at our institution to have equal or better pain relief for the regional nerve blocks as needle introduction of lidocaine.
This study seeks to evaluate the difference in pain from local anesthetic infiltration with J-tip needleless injection device compared to needle injection by use of Visual Analog Scales.
- To evaluate efficacy of femoral nerve block after J-tip device lidocaine injection post operatively by use of Visual Analog Scales.
- To assess patient and parent satisfaction with J-tip device use by satisfaction questionnaire.
- To assess changes in post operative pain medication amounts with J-tip device use.
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
- Single (Participant)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between the ages of eleven and seventeen undergoing arthroscopic knee surgery.
- •Able to independently complete the Visual Analog pain scales.
- •Subjects who are neurologically intact at area of injection.
- •English speaking.
排除标准
- •Subjects with known allergies to lidocaine.
- •Presence of developmental delay.
- •Subjects with blood disorders affecting coagulation.
- •Subjects on blood thinners.
- •Subjects receiving chemotherapeutic agents.
- •Those who use or receive analgesia prior to procedure, except for acetaminophen or Non-steroidal anti-inflammatory medications.
- •Any other local sedation at the area of nerve block injection.
- •Non-English Speaking
- •Subjects with signs of skin infection or pathology at the injection site.
结局指标
主要结局
Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale
时间窗: During Follow-up Assessment at an Average of 1 Week Post Op
Pain will be assess via the Visual Analog Scale by the patient after the knee arthroscopy though first post op office visit and average of one week. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.
时间窗: During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block
Pain will be assessed via the Visual Analog Scale by the patient before administration of the nerve block. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
次要结局
- Satisfaction Via a 0 to 10 Rating Scale at Follow up(At the follow up appointment, an average of one week after the procedure.)
研究者
Daryl Osbahr
Sports Medicine Orthopaedic physician
Orlando Health, Inc.