Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% in Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block, a Randomized, Placebo Controlled Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Primary Outcome Variable is Post Operative Sensory Block Duration
研究概览
简要总结
When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.
详细描述
The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. Therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study.
- •Ability to sign informed consent.
- •Ability to follow study protocol, and speak, read and write in English.
- •Must have valid phone number for follow-up purpose.
- •Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.
排除标准
- •Patient younger than 18 years old and older than age 70
- •Patient refusal to sign consent
- •Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
- •Allergy to any of the protocol medications
- •Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record
- •Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
研究组 & 干预措施
Bupivacaine 0.25% mixed with 1ml normal saline
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
干预措施: Bupivacaine 0.25% (Drug)
Bupivacaine 0.25% mixed with 1ml normal saline
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
干预措施: normal saline (Drug)
Bupivacaine 0.25% with 1mg dexamethasone (1ml)
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
干预措施: Bupivacaine 0.25% (Drug)
Bupivacaine 0.25% with 1mg dexamethasone (1ml)
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
干预措施: Dexamethasone (Drug)
Bupivacaine 0.25% mixed with 2mg dexamethasone
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
干预措施: Bupivacaine 0.25% (Drug)
Bupivacaine 0.25% mixed with 2mg dexamethasone
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
干预措施: Dexamethasone (Drug)
Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
干预措施: Bupivacaine 0.25% (Drug)
Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Primary Outcome Variable is Post Operative Sensory Block Duration
时间窗: days 1, 2, and day 7
This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
次要结局
- The Secondary Outcome Variable is Post Operative Motor Block Duration(days 1, 2, and day 7)