Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery. A Randomized Double-blind, Controlled Study Comparing Bupivacaine-Epinephrine 0.5% Versus Bupivacaine-Epinephrine 0.5% With Dexamethasone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Painfree period (time until first pain sensation in operated foot)
研究概览
简要总结
To extend the duration of peripheral nerve blockade after major foot and ankle surgery the investigators randomize the postoperative treatment with either perineurial sciatic nerve blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 17
- •scheduled major foot and ankle surgery
- •written informed consent
- •fertile women in anti conceptive treatment
- •fertile women not in anti conceptive treatment, but with negative urin-HCG on day of surgery
排除标准
- •patients not able to understand or cooperate
- •allergies to medicines involved
- •daily buse of steroids
- •daily use of opioids
研究组 & 干预措施
Group BAD
Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg
干预措施: Bupivacaine (Drug)
Group BA
Bupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml
干预措施: Bupivacaine (Drug)
Group BA
Bupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml
干预措施: Epinephrine (Drug)
Group BAD
Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg
干预措施: Epinephrine (Drug)
Group BAD
Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Painfree period (time until first pain sensation in operated foot)
时间窗: 48 hours
Patients are closely monitored in the PACU until first pain sensation in the operated foot.
次要结局
- Pain in the operated foot, measured on a numeric rating scale (0-10)(Every 30 minuttes from the patient enters the PACU to the nerve block wears of)
- Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot(Every 30 minutes from the patient enters the PACU to the sensations core reach 2)
- Total consumption of opioids during the length of stay(48 hours)
- quality of sleep first night measured on a 3 point scale(hours)
研究者
Rasmus Wulff Hauritz
Consultant Anesthesia
Kolding Sygehus