Postoperative subQ Pain Control for Spinal Fusion Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pain control
研究概览
简要总结
Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.
详细描述
For patients randomized to the experimental or to the placebo groups, two subcutaneous catheters will be tunneled under the skin with large hollow-bore needles along the entire length of the incision on either side prior to closure. These catheters will deliver study drug (0.25% Marcaine) directly into the incision. They will be affixed to the skin with steri-strips. The catheters will then be attached to a drug delivery pump at 2mL/hour and will be removed prior to discharge.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient 18 years of age or greater
- •Surgery to be done at Banner University Medical Center-Tucson
- •Elective Surgeries only
- •Lower Thoracic or Lumbar fusions only - Posterior Approach
- •Postero or Posterolateral Instrumented Fusions with or without Interbody graft
- •Transforaminal Interbody Fusions
- •Must be able to cooperate in the daily VAS assessment
排除标准
- •Patients under 18 years of age
- •Prisoners
- •Pregnant women
- •Hypersensitivity to infusion medication
- •Deformity Correction cases requiring osteotomies
- •Surgical fusion in acute phase for traumatic injury
- •Anterior Lumbar Interbody Fusion, Direct Lateral Interbody Fusion procedures
研究组 & 干预措施
Marciano Group
Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications.
干预措施: 0.25% Marcaine at 2ml/hr and pain medications (Drug)
Placebo Group
OnQ pump with placebo (normal saline at 2ml/hr) and pain medications.
干预措施: Placement of OnQ Drug pump (Device)
结局指标
主要结局
Pain control
时间窗: From post operative day 1 until patient discharge or 30 days, whichever comes first
A daily Visual Analog Score Pain scale (1-10) for pain severity, (1 least pain, 10 most pain) will be assessed and recorded daily by a blinded assessor.
次要结局
- Time to discharge(from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first.)
- Total Milligrams of IV pain medication(from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first)
- Total Doses of IV pain medication(from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first)
- Total Milligrams of oral pain medication(from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first)
- Total Doses of oral pain medication(from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first)
研究者
Robert Bina
Neurosurgery Resident
University of Arizona