Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Postoperative pain level
研究概览
简要总结
The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery
详细描述
Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.
Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).
Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.
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
Medication is prepared by study personell not otherwise involved in the study according to a computer generated randomization plan. This plan will be available for analyses after the study. Primary investigator is able to retreive the allocation prematurely if indicated (emergency).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Undergoing anterior cruciate ligament surgery under general anesthesia
- •ASA I-III
排除标准
- •Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics,
- •Neuromuscular disorders
研究组 & 干预措施
Levobupivacaine
Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound
干预措施: Adductor canal block (Procedure)
Levobupivacaine
Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound
干预措施: Levobupivacaine (Drug)
Placebo
Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound
干预措施: Adductor canal block (Procedure)
Placebo
Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative pain level
时间窗: Within first 48 hours after surgery
Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine
次要结局
- Opiate use(Within first 48 hours after surgery)
- Patient satisfaction(48 hours after surgery)
- Nausea(Within first 48 hours after surgery)
- Block result(within first 24 hours after surgery)
研究者
Leon Timmerman
M.D., PhD, principal investigator
St. Antonius Hospital