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临床试验/NCT05287035
NCT05287035Enrolling By Invitation早期 1 期

Perioperative IV Steroid Administration Lowers Post-operative Pain Levels and Opioid Use in Pediatric Patients After Posterior Spinal Fusion and Instrumentation for Spine Deformity.

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
Enrolling By Invitation
入组人数
70
试验地点
1
主要终点
Time to initial ambulation post-operatively and distance ambulated in first physical therapy session.

研究概览

简要总结

Current efforts to improve pain alleviation focus on non-opioid pharmaceuticals. Intravenous perioperative corticosteroid administration has been suggested as an alternative method for post-operative pain control. The evidence regarding perioperative intravenous corticosteroids to help alleviate post-operative pain is mixed. Some meta-analyses report decreased opioid consumption and decreased pain intensity after a variety of surgical procedures. However, a study of larger orthopedic procedures found no benefit. The catabolic and immunosuppressant effects of corticosteroids also pose issues with wound healing and infection, which can have severe consequences after spine surgery. There is limited data on the effect of perioperative intravenous steroid administration on pain alleviation in children having surgery to address spine deformity. A recent retrospective review demonstrated that perioperative corticosteroid administration was associated with a statistically significant decrease in opioid medication utilization among children and adolescents after spinal deformity surgery. While not increasing the risk of postoperative complications. The investigators hypothesize that the administration of perioperative intravenous dexamethasone will demonstrate a clinically meaningful and statistically significant decrease in postoperative pain intensity, need for opioid medications, time to ambulation, and length of stay in children recovering from surgery for spine deformity.

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, Care Provider, Investigator)

盲法说明

Patient and surgeon will be masked. Anesthesiologist will not be masked.

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Meets operative criteria for posterior spinal instrumented fusion for AIS
  • Parental consent

排除标准

  • Revision procedure
  • Other associated conditions which may alter the postoperative course

研究组 & 干预措施

Steroid injection

Active Comparator

Dexamethasone will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs

干预措施: Dexamethasone injection (Drug)

Saline solution

Placebo Comparator

Saline will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs

干预措施: Saline injection (Other)

结局指标

主要结局

Time to initial ambulation post-operatively and distance ambulated in first physical therapy session.

时间窗: 1 week

The investigators will assess the time to initial ambulation in reference to the surgical stop time recorded in the chart. This time will be calculated in minutes. The total minutes until first ambulation for both arms of the study will be compared. The investigators will assess measure, in feet, the distance patients ambulate during the initial session with physical therapy postoperatively. The distance, in feet, ambulated by patient in each arm of the study will be directly compared.

Length of stay in hospital

时间窗: 1 week

The investigators will measure the number of days in the hospital from the date of surgery

Morphine equivalents use

时间窗: 1 week

The investigators will record the amount of morphine equivalents utilized by patients in the post-operative in-hospital period to compare the use of intravenous narcotics in a quantifiable fashion between the two study groups.

次要结局

  • Return to emergency department(12 months)
  • Return to school(3 months)
  • Pain score at discharge(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Kaufman

Assistant Professor

University of Texas at Austin

研究点 (1)

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