Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene brachial plexus block is considered by many as the gold standard for treating postoperative pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus in the neck. Duration of analgesia is between eight to twelve hours depending on the type of administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics for a perineural injection may prolong the duration of analgesia up to 24 hours. In a meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose, without neurological complications. The objective of this multicenter randomised controlled double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that purpose, investigators will include a total of 150 patients divided in 5 groups: local anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective shoulder arthroscopy
- •duration of surgery less than 4 hours
排除标准
- •allergy to local anaesthetics
- •history of neck surgery
- •history of neck radiotherapy
- •severe respiratory disease
- •diabetic patient
- •chronic pain condition
- •pregnancy
- •patient suffering from cancer
- •patient with addicted disease
研究组 & 干预措施
Control group
Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls
干预措施: Placebo (Drug)
Control group
Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls
干预措施: Ropivacaine 0.5% (Drug)
Dex 1
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls
干预措施: Dexamethasone 1 mg (Drug)
Dex 1
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls
干预措施: Ropivacaine 0.5% (Drug)
Dex 2
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls
干预措施: Dexamethasone 2 mg (Drug)
Dex 2
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls
干预措施: Ropivacaine 0.5% (Drug)
Dex 3
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls
干预措施: Dexamethasone 3 mg (Drug)
Dex 3
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls
干预措施: Ropivacaine 0.5% (Drug)
Dex 4
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls
干预措施: Dexamethasone 4 mg (Drug)
Dex 4
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls
干预措施: Ropivacaine 0.5% (Drug)
结局指标
主要结局
Duration of analgesia
时间窗: 24hour
次要结局
- Equivalent morphine consumption in postanesthetic care unit(4hour)
- Equivalent morphine consumption on postoperative day 1(24hour)
- Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)(4hour)
- Onset time of action of motor block(1hour)
- Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)(4hour)
- Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)(24hour)
- Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)(24hour)
- Rate of postoperative nausea and vomiting (PONV)(24hour)
- Rate of pruritus(24hour)
- Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)(24hour)
- Glycemia in postanesthetic care unit (mmol/l)(4hour)
- Duration of motor block(24hour)
- Onset time of action of sensory block(1hour)
- Rate of infection(7 days)
- Rate of paresthesia(7 days)
- Rate of muscle weakness(7 days)
研究者
Eric Albrecht
PD MD, Program director of regional anaesthesia
Centre Hospitalier Universitaire Vaudois