跳至主要内容
临床试验/NCT06367855
NCT06367855招募中4 期

Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF

Potsawat Surabotsopon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
effectiveness of dexamethasone

研究概览

简要总结

Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes.

详细描述

Surgery for spine fusion through a minimally invasive technique called MIS-TLIF has become increasingly popular nowadays due to various reasons such as lower blood loss and reduced need for blood transfusions, less postoperative back pain, and shorter surgical duration compared to the traditional technique known as TLIF. However, even after MIS TLIF, patients still experience issues such as wound or back pain, which can affect their physical activity and increase the risk of infection. Prolonged hospital stays lead to resource wastage.

In the Enhanced Recovery After Surgery (ERAS) program for spine surgery, preoperative medication, including Acetaminophen, NSAIDs, and Gabapentinoids, is recommended to alleviate postoperative back pain. However, even after implementing ERAS, patients undergoing MIS TLIF still experience pain, suggesting that further pain reduction strategies are needed. The use of Dexamethasone as preemptive medication has shown promising results in various surgeries, with minimal side effects and a manageable cost. Dexamethasone, administered via injection, has a longer duration of action compared to other steroids, making it suitable for preemptive use.

The main objective is to study the effectiveness of using Dexamethasone via intravenous injection before minimally invasive spine fusion surgery, known as MIS-TLIF, in reducing postoperative back pain.

The secondary objectives are to compare the rate of morphine usage for pain management after surgery between two groups.

To compare the side effects and adverse reactions of the medication, such as nausea and vomiting, surgical site infection rates, and blood sugar levels post-surgery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range: 50-80 years old.
  • Undergoing MIS TLIF surgery at 1-2 spinal levels.

排除标准

  • Previously undergone spine surgery.
  • HbA1C greater than or equal to 7.5 mg%
  • Allergic to all types of experimental medication.
  • History of using systemic steroids.

研究组 & 干预措施

Dexamethasone group

Active Comparator

干预措施: Dexamethasone (Drug)

Normal saline group

Placebo Comparator

干预措施: Normal saline (Drug)

结局指标

主要结局

effectiveness of dexamethasone

时间窗: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period

postoperative VAS score at rest and motion for back pain

次要结局

  • Morphine consumption(24 hours post operative period)
  • Complication(24 hours, 2 weeks, 6 weeks, 12 weeks post operative period)
  • Fusion rate(6months)
  • Length of hospital stay(1 year)

研究者

发起方
Potsawat Surabotsopon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Potsawat Surabotsopon

MD

Thammasat University Hospital

研究点 (1)

Loading locations...

相似试验