Impact of Two Doses of Intravenous Dexamethasone on the Analgesic Duration of a Single-shot Interscalene Block With Ropivacaine for Shoulder Arthroscopy; a Prospective, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Duration of Analgesia
研究概览
简要总结
Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.
详细描述
75 patients will be randomly assigned to three groups:
- D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
- D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
- C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.
All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.
In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached >3/10. They will note the time and day at which this outcome occurs.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
- •ASA I-III
- •Age 18-80 years old
排除标准
- •Any contraindication to interscalene brachial plexus block anesthesia
- •Interscalene brachial plexus block failure
- •Known local anesthetics allergy
- •Dexamethasone allergy or intolerance
- •Any contraindication to acetaminophen
- •Any contraindication to morphine or hydromorphone
- •Brachial plexus neuropathies
- •Chronic pain syndrome other than shoulder pain
- •Routine use of opioid medication
- •Routine use of systemic corticosteroid
- •Pregnancy
- •Weight below 50 kilograms
- •Incapability to understand a numeric verbal pain scale
- •Incapability to consent
- •Patient refusal
研究组 & 干预措施
Normal Saline 20 mL intravenous
Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
干预措施: Normal Saline (Drug)
Dexamethasone 10 mg intravenous
Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block
干预措施: Dexamethasone (Drug)
Dexamethasone 4 mg intravenous
Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Duration of Analgesia
时间窗: 48 hours after surgery
Defined as the time between the performance of the block and the first analgesic request
次要结局
- Pain Scores(every 6 hours during the first 48 hours after surgery)
- Residual Motor Block(24 hours and 48 hours)
- Patients Overall Satisfaction(48 hours)
- Sleep Disturbance(24 hours and 48 hours)
研究者
Veronique Brulotte
Dre Veronique Brulotte, MD, M.Sc, FRCPC, anesthesiologist
Maisonneuve-Rosemont Hospital