Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- First need of opiate
研究概览
简要总结
Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery
详细描述
This study is proposed to explore the effect of perineural dexamethasone on the duration of popliteal nerve block for analgesia after ankle surgery.
After ankle or foot arthrodesis patients need a good analgesia. Nevertheless early mobilisation and discharge are important for the healing process after surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. Perineural dexamethasone added to local anesthetic prolongs the duration of analgesia of the perineural nerve block.
The perineural use of dexamethasone is still off-label. There is a ongoing discussion of which has better benefits, intravenous or perineural dexamethasone.
There are multiple research where the intravenous and perineural dexamethasone use has compared, but there is still a limited amount of research of low dose perineural dexamethasone versus intravenous dexamethasone.
In this study investigators compare different doses of perineural dexamethasone added to ropivacaine 2 mg/ml 20ml. After arthrodesis under spinal anaesthesia the patients receive popliteal block ropivacaine 2 mg/ml 20 ml and dexamethasone of different doses. Groups 1 to 4 has dexamethasone doses 0, 2mg, 3mg or 4 mg.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult people under ankle/foot arthrodesis as a curative therapy of ankle arthrosis or situation after ankle injury or malposition
排除标准
- •Age under 18 years Complicated diabetes mellitus Lack of finnish language skill and/or co-operation Chronic pain Steroid medication in regular use
研究组 & 干预措施
DEXA0
Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally
干预措施: Ropivacaine Hydrochloride Inj 2 mg/ml (Drug)
DEXA0
Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally
干预措施: Sodium Chloride 9mg/mL (Drug)
DEXA1
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,2 ml and Sodium Chloride 9mg/mL 0,8 ml perineurally
干预措施: Dexamethasone Sodium Phosphate (Drug)
DEXA1
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,2 ml and Sodium Chloride 9mg/mL 0,8 ml perineurally
干预措施: Ropivacaine Hydrochloride Inj 2 mg/ml (Drug)
DEXA1
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,2 ml and Sodium Chloride 9mg/mL 0,8 ml perineurally
干预措施: Sodium Chloride 9mg/mL (Drug)
DEXA2
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,4 ml and Sodium Chloride 9mg/mL 0,6 ml perineurally
干预措施: Dexamethasone Sodium Phosphate (Drug)
DEXA2
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,4 ml and Sodium Chloride 9mg/mL 0,6 ml perineurally
干预措施: Ropivacaine Hydrochloride Inj 2 mg/ml (Drug)
DEXA2
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,4 ml and Sodium Chloride 9mg/mL 0,6 ml perineurally
干预措施: Sodium Chloride 9mg/mL (Drug)
DEXA4
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,8 ml and Sodium Chloride 9mg/mL 0,2 ml perineurally
干预措施: Dexamethasone Sodium Phosphate (Drug)
DEXA4
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,8 ml and Sodium Chloride 9mg/mL 0,2 ml perineurally
干预措施: Ropivacaine Hydrochloride Inj 2 mg/ml (Drug)
DEXA4
Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,8 ml and Sodium Chloride 9mg/mL 0,2 ml perineurally
干预措施: Sodium Chloride 9mg/mL (Drug)
结局指标
主要结局
First need of opiate
时间窗: 48 hours
Time after surgery when the patient needs opiate for the first time
次要结局
- Opiate consumption(48 hours)
- Pain(postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 28 hours, 32 hours, at 36 hours, at 40 hours, at 44 hours, at 48 hours,seventh postoperative day)
- Mobilisation(postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 28 hours, 32 hours, at 36 hours, at 40 hours, at 44 hours, at 48 hours)
- Blood glucose(postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours)