The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block
研究概览
简要总结
This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.
详细描述
This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups:
- Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;
- Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);
- Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;
- Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.
The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge.
Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression
排除标准
- •Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis)
- •Pregnancy
- •Pre-existing neuropathy involving the surgical limb
- •Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery
- •Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)
研究组 & 干预措施
Group 3
Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml)
干预措施: ropivacaine (Drug)
Group 1
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
干预措施: saline (Drug)
Group 1
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
干预措施: ropivacaine (Drug)
Group 2
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
干预措施: saline (Drug)
Group 2
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
干预措施: Bupivacaine (Drug)
Group 3
Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml)
干预措施: Dexamethasone (Drug)
Group 4
Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml).
干预措施: Dexamethasone (Drug)
Group 4
Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml).
干预措施: Bupivacaine (Drug)
结局指标
主要结局
The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block
时间窗: Postoperative day 1, 2 and 3
次要结局
- Median Maximum VAS Pain Scores at Rest(Postoperative day 1, 2 and 3)
- Time to First Report of Pain(Postoperative day 1, 2 and 3)
- Total Three-day Opioid Consumption in Oral Oxycodone Equivalent(Postoperative day 1, 2 and 3)