Does Saphenous Nerve Block Improve Analgesia After Total Knee Replacement When Used in Combination With Local Infiltration Analgesia? A Prospective Randomised Double Blinded Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain on movement at 24 hours time point post operatively
研究概览
简要总结
We hypothesize that preoperative saphenous nerve block (SNB) in combination with periarticular local infiltration provides better post operative pain relief (POPR) profile as compared to local infiltration alone
详细描述
Introduction:
Local infiltration analgesia (LIA) is considered acceptable after total knee replacements (TKR) in terms of analgesia, ease of performance, early mobilization and early hospital discharge . Continuous femoral nerve block has been used to enhance post op pain relief (POPR) for TKR but at the expense of motor blockade . A Sub sartorial approach to saphenous nerve block (SNB) spares the motor block . To date the role of saphenous nerve block for POPR in TKR has not been evaluated.
Methodology:
In order to test this hypothesis, we proposed to carry out a prospective randomized controlled double blinded (surgeon and assessor) trial study. With institutional ethics approval and having obtained written informed consent from each patient, 20 ASA 1 - 3 patients scheduled to undergo TKR under spinal anesthesia +/- sedation were allocated to one of two groups i.e. Group (SNB): patients receiving SNB sub sartorial approach and Group (NSNB): patients not receiving SNB.
Group allocation was determined using computer generated random number tables. Sealed envelopes were opened on the day of the surgery by the attending anesthetist responsible for the care of the recruited patient.
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
- 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
- •American Society of Anaesthesia (ASA) Grade I-lll patients Undergoing elective Total Knee Arthroplasty Patients able to consent and understand all the components of the study.
排除标准
- •Demented patients Patients having bilateral Knee Replacements Patients unable to comprehend the use of pain scales Allergy to any of the medications used in the study Renal dysfunction Coagulation disorders Peptic ulcer disease precluding use of non-steroidal anti-inflammatory drugs (NSAIDs) Patients unable to use regular opioid medication Any chronic pain condition other than osteoarthritis of the knee.
结局指标
主要结局
Pain on movement at 24 hours time point post operatively
时间窗: 24 hours hours time point
次要结局
- pain on movement at 6 and 12 hour time point(6 and 12 hours time points)
- pain at rest at 6, 12 and 24 hours time points(6, 12 and 24 hours time points)
- Maximum Knee Flexion at 6, 12 and 24 hours time points(6, 12 and 24 hours time points)
- Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points(6, 12 and 24 hours time points)
- Time to First request for rescue analgesia(24 hours)
- Cumulative Opioid consumption in 24 hours(24 hours)
- Cumulative opioid consumption till discharge(till discharge time)
- 6 Minute walk test(At 24 hours Post block Conduction)
研究者
DR. Jassim Rauf
Specialist Registrar
Cork University Hospital