Comparison Between Single Shot Peripheral Nerve Block and Continuous Infusion Via a On-Q Pump in Extremity Fracture Operations: a Randomized Prospective Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Score on Visual Analog Scale (VAS)
研究概览
简要总结
Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a "rebound pain"--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.
详细描述
Purpose The purpose of this randomized prospective study will be to compare post-operative pain control after extremity fracture fixation surgery between patients who receive single shot versus continuous peripheral nerve blocks.
Scientific or Scholarly Rationale Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery 1-4. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. Airway manipulations are avoided, post-operative nausea and vomiting are diminished, post-anesthesia care unit stay are shortened, and fewer nursing interventions in the post-anesthesia care unit are required5-6.
Patients who have operative fixation of extremity fractures (ankle, wrist, forearm) are typically ambulatory patients. However, many become hospitalized overnight secondary to inadequate pain control, increasing hospital costs. Goldstein et al. showed that patients who underwent popliteal blocks after ankle fracture fixation demonstrated significantly better pain control immediately postoperatively7. The need for overnight hospitalization secondary to pain is decreased, as are nonsurgical operating room times.
Despite the success of regional anesthesia, a phenomenon known as "rebound pain" has been shown to occur as the original block wears off7-9. Patients with blocks will experience significantly increased pain compared to those without blocks approximately 12-24 hours after surgery. This can be controlled with early narcotic administration but can be a source of significant discomfort to a patient if not recognized and treated in time. A few studies have shown that continuous infusions of various numbing agents are efficacious in prolonged pain control, even in the ambulatory setting10-12. Nevertheless, no studies have thus performed a randomized prospective control trial studying the efficacy of continuous infusion therapy on pain control following extremity fracture surgery.
Aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years old.
- •Male or Female
- •All racial and ethnic groups
- •Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand
- •Patients who opt for surgical treatment of their fractures.
- •Patients who consent to be randomized.
- •Patients who are willing to follow-up for a minimum of 52 weeks.
排除标准
- •Patients younger than 18 years old.
- •Patients who are on chronic opioids
- •Patients who abuse opioids
- •Patients who are unwilling to follow-up for a minimum of 52 weeks.
- •Neurologic condition that could interfere with pain sensation
研究组 & 干预措施
Ankle Single Shot Block (SSB)
干预措施: Ankle SSB (Drug)
Ankle OnQ (Continuos Sedation OnQ Pump)
干预措施: Ankle OnQ (Drug)
DR SSB
干预措施: DR SSB (Drug)
DR OnQ
干预措施: DR OnQ (Drug)
结局指标
主要结局
Change in Score on Visual Analog Scale (VAS)
时间窗: 2 weeks, 6 weeks
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").
次要结局
- Disability of the Arm, Shoulder and Hand (DASH) Score(2 Weeks, 6 Weeks)