Use of Regional Anesthesia in Hip Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Subject log to record number of pain pills taken by subject for 7 days
研究概览
简要总结
The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.
详细描述
Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement
- •Age 18-45 years old
- •Not pregnant
- •No history of neuropathic pain
- •No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)
- •Willing and able to comply with post-operative hip arthroscopy protocol
- •No documented allergy to anesthetic agents
- •Able to attend follow up appointments
排除标准
- •Allergy to regional anesthetic
- •Age <18 or >45 years
- •Pregnant females
- •History of neuropathic pain
- •Radiographic signs of osteoarthritis (Tönnis grade 2)
- •Unable to speak/understand English
- •Currently imprisoned
- •Unwilling/unable to provide consent
研究组 & 干预措施
regional anesthesia bupivacaine
regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy
干预措施: regional anesthesia bupivacaine (Drug)
regional anesthesia placebo
subcutaneous injection procedure placebo (0.9% sodium chloride in water)
干预措施: regional anesthesia placebo (Drug)
结局指标
主要结局
Subject log to record number of pain pills taken by subject for 7 days
时间窗: 7 days
A log that is used by the subject to record how many oral pain medications they take for 7 days.
次要结局
- Duration of time in PACU(immediately post-op, on average between 1-4 hours)
- Visual analog pain scale(6 weeks)
- Reported Falls Post-op(Time inpatient, on average 12-48 hours)
- iHOT-12 (international hip outcome tool)(6 weeks)
- Patient satisfaction(6 weeks)
- Record of Pain Medication given in PACU(immediately post-op (while in PACU, on average 1-4 hours total))
- Harris Hip score(6 weeks)
- Unplanned admissions and/or readmissions(6 weeks)
- HOOS (hip disability and osteoarthritis outcome score)(6 weeks)
- Days until starting rehabilitation(immediately post-op, on average 24 hours - 2 weeks)
研究者
Ajay Aggarwal
Assistant Professor of Orthopedic Surgery
University of Missouri-Columbia