Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Narcotic Use
研究概览
简要总结
The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. The investigators will be measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse events and fracture union. The investigators hypothesize that this multimodal regimen will lead to improved pain, less narcotic use and improved satisfaction as compared to the standard regimen.
详细描述
Patients will be assessed for inclusion or exclusion during admission to the hospital or during evaluation in the clinic or emergency room for an isolated extremity fracture for which surgery is indicated. Once enrolled in the study and consent obtained, patients will be randomized into either the standard therapy group or the multimodal therapy group using permuted block randomization based on injury site. The sites of fracture are as follows:
- wrist/hand/forearm
- elbow/upper arm/shoulder
- acetabulum/pelvis
- foot/ankle
- patella/tibia (shaft, proximal)
- femur (proximal to distal)
The investigators have assumed that these distinct areas result in a similar amount of disability and pain as compared to the other sites. This is an attempt to mitigate the possible confounder of disproportionate numbers of more painful or more debilitating injuries falling in one study group compared to another.
Pre-operatively, patient demographic data will be recording including age, gender, BMI, hand dominance, occupation, use of tobacco/alcohol/illicit drugs, use of assistive devices, relevant comorbidities (i.e., diabetes), site of injury, mechanism and energy (high or low). If there is to be a delay between initial presentation and surgery, as is often the case for distal radius or ankle fractures, among others, multimodal patients will begin their therapy immediately after evaluation. Thus, they will be started on scheduled 1000mg acetaminophen and 100mg gabapentin both three times daily. They will also be provided an 5mg oxycodone prescription with instructions to take 1-3 tablets every 4 hours as needed for pain. Standard therapy patients will be prescribed oxycodone alone, using the same parameters, with the ability to take acetaminophen on an as needed basis.
Pre-operatively, multimodal patients will receive 1000mg IV acetaminophen, 100mg PO gabapentin and 400mg PO celecoxib. All patients will have a peripheral nerve block placed when indicated, to confirm to the investigators standard of care. Patients will then undergo surgery with the investigators standardized anesthesia protocol as described in the protocol. Intraoperatively, multimodal patients will receive 8mg of IV dexamethasone. Post-operatively, multimodal patients will be given 1000mg acetaminophen three times daily for the duration of their narcotic use and 100mg Gabapentin three times daily for 1 week, which will be titrated to 200mg three times daily for 1 additional week. They will also receive an oxycodone prescription as described previously. Standard therapy patients will be given an oxycodone prescription alone with the advice to take tylenol on an as needed basis not to exceed 4000mg/day. No placebo medications will be used as this is an open label study.
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
- •Bone fracture
- •Isolated injury
- •Requires operative intervention
排除标准
- •pathological fractures
- •inability to personally consent to participation due to cognitive impairment, intoxication or sedation
- •severe head injury
- •polytrauma patients with multiple fractures or other injuries
- •pregnancy
- •open fractures
- •metabolic bone disease
- •allergies or contraindications to the study medications, including sulfa medications.
- •prior or current drug or alcohol dependence or abuse
- •liver or kidney disease
- •physician directed narcotic use
研究组 & 干预措施
Multimodal pain control
Oxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op.
干预措施: Gabapentin (Drug)
Multimodal pain control
Oxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op.
干预措施: Acetaminophen (Drug)
Multimodal pain control
Oxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op.
干预措施: Celecoxib (Drug)
Standard pain control
Oxycodone 5-15mg PO q4hrs prn, Acetaminophen 1000mg PO q8hrs prn.
干预措施: Oxycodone (Drug)
Multimodal pain control
Oxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op.
干预措施: Dexamethasone (Drug)
Multimodal pain control
Oxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op.
干预措施: Oxycodone (Drug)
Standard pain control
Oxycodone 5-15mg PO q4hrs prn, Acetaminophen 1000mg PO q8hrs prn.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Narcotic Use
时间窗: 2 months
Measurement of both daily narcotic use in milligrams as well as the duration of narcotic treatment in days.
Patient Satisfaction
时间窗: 3 months
Measurement of patient satisfaction with pain control regimen using the American Pain Society's Patient Outcome Questionnaire (APS-POQ).
Pain
时间窗: 6 months
VAS score for pain control, daily for two weeks post op and at all follow up visits for 6 months.
次要结局
- Patient function(6 months)
- Fracture Union(6 months)
- Adverse events(6 months)
