Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy
研究概览
简要总结
Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks. However, these studies only used fixed doses of IV dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. There remains a paucity of research on the effective dose range of IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular blocks in shoulder surgery has yet to be delineated.
详细描述
Numerous studies have confirmed that perineural dexamethasone prolongs bupivacaine and ropivacaine brachial plexus blocks by approximately 10 hours (from approx. 12 to 22 hours) without clinical evidence of toxicity. However, perineural toxicity in an animal model has raised concern about its use as a peripheral nerve block adjuvant. Moreover, recent studies suggest that high dose IV dexamethasone (810mg) prolongs analgesia to a similar degree as perineural dexamethasone for interscalene, supraclavicular and sciatic nerve blocks performed with ropivacaine and bupivacaine. However these studies only utilized fixed, high level doses of IV dexamethasone. Moreover, there remains a concern that high dose IV dexamethasone may lead to postoperative hyperglycemia and could possibly increase the risk of postoperative wound infection. Open surgery under general anesthesia has been shown to increase blood glucose levels with a peak at approximately 2 hours post-induction and results have been conflicting regarding whether or not IV dexamethasone causes greater increase. To the investigators' knowledge, it is not yet known if arthroscopic surgery under regional anesthesia triggers a similar increase in blood glucose levels and if this is impacted by administration of IV dexamethasone. The investigators aim to identify the duration of supraclavicular block prolongation that can be expected over a range of doses of IV dexamethasone. The investigators also seek to identify what association, if any, is noted between IV dexamethasone and changes in blood glucose levels after shoulder surgery with regional anesthesia and sedation. Finally, the investigators will collect data on side effects and postoperative complications, if any, in patients receiving a range of doses of IV dexamethasone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Patients undergoing shoulder arthroscopy under regional anesthesia
排除标准
- •General anesthesia
- •Contraindication to regional anesthesia
- •Pre-existing neuropathy in the surgical limb
- •Diabetes Mellitus
- •History of postoperative nausea and vomiting &/ or motion sickness
- •Procedures involving biceps tenotomy
- •Peri-articular cocktail injections given intraoperatively to augment pain relief
- •Chronic pain (daily opioid and/or gabapentinoid use for 6 weeks)
- •Open surgical procedures
- •Corticosteroid injection within 1 month
- •Patients on systemic oral or IV steroid therapy within 6 months
研究组 & 干预措施
6mg IV Dexamethasone
6mg IV Dexamethasone
干预措施: IV Dexamethasone 6mg (Drug)
0mg IV Dexamethasone
0mg IV Dexamethasone
干预措施: IV Saline (Drug)
4mg IV Dexamethasone
4mg IV Dexamethasone
干预措施: IV Dexamethasone 4mg (Drug)
8mg IV Dexamethasone
8mg IV Dexamethasone
干预措施: IV Dexamethasone 8mg (Drug)
结局指标
主要结局
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy
时间窗: Day of Surgery until Post-Operative Day 3 (if the block persists)
Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.
次要结局
- Duration of Motor Block From the Supraclavicular Block(Day of Surgery until Post-Operative Day 3 (if the block persists))
- Occurrence of Postoperative Neuropraxia(Post-Operative Day 21)
- Blood Glucose Levels(Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration)
- Occurrence of Postoperative Wound Infection(Post-Operative Day 21)
- Average Daily Pain Scores at Rest and With Movement(Day of Surgery until Post-Operative Day 3 (if the block persists))
- Worst Daily Pain Scores at Rest and With Movement(Day of Surgery until Post-Operative Day 3 (if the block persists))
- Patient Satisfaction With Postoperative Analgesia(Post-Operative Day 2 or Post-Operative Day 3 (if the block persists))
- Cumulative Daily Opioid Usage(Recovery Room until Post-Operative Day 3 (if block persists))