The Effects of Perineural Versus Intravenous Dexamethasone on Sciatic Nerve Blockade Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of Recovery
研究概览
简要总结
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.
详细描述
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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
- •ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia.
- •Surgery confined to the foot and ankle.
- •Patients aged 18-70 years.
排除标准
- •ASA Classification of 4 or higher.
- •Pre-existing neuropathy
- •Coagulopathy
- •Infection at the site
- •Non-English speaking or reading patients
- •Systemic use of corticosteroids within 6 months of surgery
- •Chronic opioid use
- •Pregnancy
- •Large (>3cm) skin incision around the medial aspect of the foot
- •Any other contra-indication to regional anesthesia
研究组 & 干预措施
Perineural Dexamethasone
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL, and 50mL IV normal saline infusion
干预措施: Dexamethasone (Drug)
Intravenous Dexamethasone
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and IV dexamethsone 8mg in 50mL infusion
干预措施: Dexamethasone (Drug)
No Perioperative Steroids
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion
干预措施: Saline (Drug)
结局指标
主要结局
Quality of Recovery
时间窗: 2 weeks
QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.
次要结局
- Opioid Consumption(2 weeks)
- Pain Scores(2 weeks)
研究者
Rohit Rahangdale
Assistant Professor of Anesthesiology
Northwestern University