Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Pain Score at 12 Months - Experimental Group vs. Control Group
研究概览
简要总结
This pilot study will test the hypothesis that prolonged regional peripheral nerve block will reduce development of chronic pain in patients undergoing surgery for ankle fracture compared to standard of care. Subjects will be followed for one year.
详细描述
This pilot study will test the hypothesis that prolonged regional peripheral nerve block will reduce development of chronic pain in patients undergoing surgery for ankle fracture. Regional nerve block using local anesthetics delivered by ambulatory pump is used in some types of surgeries but is not routine for ankle fracture patients in our hospitals. Patients will be randomized to standard care (single shot peripheral nerve block prior to surgery) or experimental (the same single shot nerve block, followed by continuous popliteal nerve block with ropivacaine starting just after surgery). The primary outcome will be scores on a validated ankle/foot pain questionnaire that includes questions on function. Subjects will be followed for one year. Secondary outcome will be postoperative opioid use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for surgery for open reduction and internal fixation for ankle fracture
排除标准
- •Unable to give informed consent in English
- •Unable to complete surveys in English
- •Unable to understand instructions for using pump in English
- •Unavailable for followup
- •Polytrauma; undergoing other surgeries or having other orthopedic injuries related to the precipitating cause of the ankle fracture
- •Infection
- •Peripheral vascular disease
- •Currently undergoing chemotherapy
- •Pregnancy
- •Currently lactating
- •Heart disease or heart rhythm disorder or taking anti-arrhythmic drugs
- •Severe renal impairment (Class 3 or worse kidney disease)
- •Liver disease (cirrhosis or liver failure)
- •Prior allergic reaction to any type of local anesthetic
- •Taking therapeutic doses of anti-coagulants or anti-platelet therapy (prophylactic doses started because of hospital admission are not an exclusion)
- •Currently taking antidepressants or other psychiatric medications
- •Single shot local nerve block prior to surgery was ineffective
- •Selected for neuraxial anesthesia rather than general anesthesia for the open reduction surgery
- •Already receiving chronic analgesic therapy for a separate chronic pain condition
研究组 & 干预措施
Ropivacaine
Single injection of ropivacaine immediately prior to surgery
干预措施: Ropivacaine (Drug)
Ropivacaine plus Nerve Block
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
干预措施: Ropivacaine (Drug)
Ropivacaine plus Nerve Block
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
干预措施: Nerve block (Procedure)
结局指标
主要结局
Pain Score at 12 Months - Experimental Group vs. Control Group
时间窗: at 12 months post surgery
Patients will complete Self-Administered Foot and Ankle Questionnaire (SEFAS) at 12 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome.
次要结局
- Pain Score at 2 Weeks - Experimental Group vs. Control Group(at 2 weeks post surgery)
- Pain Score at 3 Months - Experimental Group vs. Control Group(at 3 months post surgery)
- Pain Score at 6 Months - Experimental Group vs. Control Group(at 6 months post surgery)
- Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group(at 1 year post surgery)
研究者
Jun-ming Zhang
Professor of Anesthesia
University of Cincinnati