Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time it Takes for Nerve Block to Wear Off
研究概览
简要总结
Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.
Primary outcome:
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
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
- 否
入选标准
- •Patients of Dr Levine or Dr Roberts.
- •Scheduled for discharge from HSS after foot or ankle surgery.
- •A single-injection popliteal fossa nerve block is judged appropriate.
- •Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
- •Patients aged 18-75 years.
排除标准
- •Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
- •Bilateral surgery
- •Chronic pain (defined as regular use of opioid analgesics for > 3 months).
- •Chronic use of steroids (defined as regular use of steroids for > 3 months).
- •Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).
- •Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)
- •Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia).
- •Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)
研究组 & 干预措施
Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.
干预措施: B. Nerve Block with Dexamethasone (4 mg). IV saline. (Drug)
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
干预措施: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). (Drug)
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
干预措施: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) (Drug)
Control Nerve Block. IV Dexamethasone (4 mg).
Control Nerve Block. IV Dexamethasone (4 mg).
干预措施: A. Control Nerve Block. IV Dexamethasone (4 mg). (Drug)
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
干预措施: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). (Drug)
结局指标
主要结局
Time it Takes for Nerve Block to Wear Off
时间窗: up to 72 hours
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
次要结局
未报告次要终点