Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Lifespan
- 试验地点
- 1
- 主要终点
- Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block.
研究概览
简要总结
The purpose of this study is to determine the Finger Blood Glucose (sugar) when dexamethasone is added to a local anesthetic for a shoulder nerve block procedure. The investigators hypothesize that there is no increase in plasma glucose when 8 mg of dexamethasone is used as an adjuvant with local anesthetic to interscalene regional anesthesia. By performing finger stick blood glucose measures pre/peri and post operatively the investigators will be able to determine if any such increase exists.
详细描述
Patients receiving regional anesthesia for orthopedic surgeries are provided with significant pain relief in the post-operative period. Dexamethasone as an adjuvant to local anesthetic has been shown to provide increased duration of block without adverse effects. Use of steroids as adjuvants are restricted to non-diabetics due to concern for increased plasma glucose from systemic absorption. The investigators hypothesize that there will be no difference(increase) from patient baseline(preoperative plasma glucose) in plasma glucose levels up to 4 hours post nerve block in patients who receive 8 mg of dexamethasone used as an adjuvant with local anesthetic to interscalene regional anesthesia. Research has demonstrated the safety and efficacy of dexamethasone as an adjuvant to local anesthetic in peripheral nerve block. Currently there are no studies which document any plasma glucose effects(or lack of effects) from dexamethasone used as an adjuvant to regional anesthesia. Currently dexamethasone is used clinically off label by anesthesiologists as an adjuvant in association with local anesthetic for nerve block anesthesia. Once studies are completed, the investigators hope to allow diabetics to also receive the prolongation of pain relief associated with the use of steroid as an adjuvant. In addition, the increased educational and pharmacological data gleamed from the data can potentially be utilized for future studies with dexamethasone utilized perineurally.
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, 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
- 是
入选标准
- •ASA 1 or ASA 2 male or female non pregnant patients undergoing elective shoulder arthroscopy for surgical repair.
排除标准
- •severe lung disease
- •contralateral diaphragmatic paralysis
- •coagulopathy
- •pregnancy
- •pre-existing neuropathy involving the surgical limb
- •systemic use of corticosteroids for 2 weeks or longer within 6 months of surgery
- •chronic opioid use (30 mg oral oxycodone equivalent per day)
- •diabetes I or II
- •diagnosis of "pre-diabetes"
- •currently prescribed any of the oral glucose medications :sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, or DPP-4 inhibitors.
研究组 & 干预措施
Bupivacaine
50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.
干预措施: Bupivacaine (Drug)
Dexamethasone and Bupivacaine
50 randomized participants in group will 8 mg(2cc of 4mg/cc solution) Dexamethasone added to 20 cc 0.25% bupivacaine in one syringe resulting in 364 µgm/cc for injection. Injected perineurally for interscalene nerve block pre-operatively.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block.
时间窗: 4 hours
Normal fasting blood glucose is defined by investigators as less than 100mg/dL.(current literature suggests normal is 70-100 so investigators have chosen to utilize high normal.) Any increase greater than 10%(or 10mg/dL ) would be considered a response to the dexamethasone.
次要结局
- Pain post-operative(immediately)- both at rest and with movement(VAS Scale)(4 hours)
- Time until first narcotic usage post operatively(14 days)
- Block Quality and Duration(time until first motor return)(14 Days)
- Block Quality and Duration(time until first sensory return)(14 Days)
研究者
Geoffrey Wilson, M.D.
Staff Anesthesiologist, Principal Investigator
United States Naval Medical Center, Portsmouth