Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of steps walking ability assessed by GAITRITE Test
研究概览
简要总结
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
- Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
- Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital.
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
详细描述
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years old
- •patient covered by social health insurance
- •have signed written informed consent
- •scheduled for hallux valgus ambulatory surgery
排除标准
- •protected patients or patients incapable of giving written informed consent
- •pregnant or breastfeeding woman
- •vulnerable adult
- •inability to participate in pain scoring scales
- •severe coagulopathy
- •allergy or contraindications to study drugs
- •preoperative gait disorders
- •chronic kidney disease with glomerular filtration rate (GFR) ≤ 50 ml/min (estimated by the Cockcroft and Gault formula)
- •severe chronic liver disease
- •chronic pain (treated by non steroidal anti inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)
- •peripheral neuropathy
- •intervention under general anesthesia
研究组 & 干预措施
plantar block
Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
干预措施: PLANTAR BLOCK (Procedure)
Sciatic popliteal block
Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
干预措施: Sciatic popliteal block (Procedure)
结局指标
主要结局
Number of steps walking ability assessed by GAITRITE Test
时间窗: 6 hours after ALR
Comparison of the deambulation assessed by GAITRITE test (walking test) between patient who received plantar block and patient who received sciatic popliteal block
次要结局
- Assessment of the quality of the sensory blocks(during the surgery)
- Assessment of the patient hospitalisation duration(up to 3 days after surgery)
- Assessment of overall patient satisfaction assessed by the scale EVAN Loco regional(up to 3 days after surgery)
- Efficacity of patient walking ability(up to 3 days after surgery)
- Quantity of postoperative rescue analgesics taken(up to 3 days after surgery)
- Assessment of sleep quality Assessment of patient sleep quality(up to 3 days after surgery)