Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used
研究概览
简要总结
This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture
排除标准
- •Pregnant women
- •Treatment with Arthroplasty
- •Patients who receive a peripheral nerve block
- •Patients who receive intra-op or post-op ketamine
- •Patients with concomitant TBI or MR
- •Polytrauma patients
- •Pathologic Fractures
- •Patients who live greater than 10 miles from NYU or who will not be followed by an NYU provider
- •Patients with a contraindication to any of the medications on the study list due to other medical problems such as renal or liver disease or due to allergy/intolerance
- •Patients with prior extremity weakness resulting from stroke or other neurological condition
- •Prior or current history of narcotic use
- •Patients with advanced dementia
- •NYUMC Students, Residents, Faculty
研究组 & 干预措施
Spinal Anesthesia
Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
干预措施: Marcaine, Duramorph , ketorolac (Drug)
Spinal Anesthesia
Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
干预措施: Bupivacaine (Marcaine) (Drug)
General Anesthesia
The control group will receive no injection into area surrounding the fracture site
干预措施: General Anesthetics (Drug)
结局指标
主要结局
Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used
时间窗: Post-Operative Day 0
Number of mgs taken of oral morphine
Ambulation Distance
时间窗: Post-operative Day 3
Ambulation is the ability to walk without the need for any kind of assistance. It is most often used when describing the goals of a patient after a surgery or physical therapy.
Score on Visual Analogue Scale (VAS) for Pain
时间窗: Hour 24
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
次要结局
未报告次要终点