Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF

Обзор

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.

Подробное описание

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.

To compare the fusion rates of the spinal bones. To compare the length of hospital stays after surgery.

Вмешательства

• Препарат Dexamethasone
  long-acting corticosteroid IV route
• Препарат Normal saline
  normal saline

Первичные конечные точки

• effectiveness of dexamethasone [Срок оценки: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period]

Вторичные конечные точки (4)

• Morphine consumption [Срок оценки: 24 hours post operative period]
• Complication [Срок оценки: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period]
• Fusion rate [Срок оценки: 6months]
• Length of hospital stay [Срок оценки: 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• Thammasat university hospital — Pathum Thani

Публикации

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• De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2. PMID 21799397
• Tammachote N, Kanitnate S. Intravenous Dexamethasone Injection Reduces Pain From 12 to 21 Hours After Total Knee Arthroplasty: A Double-Blind, Randomized, Placebo-Controlled Trial. J Arthroplasty. 2020 Feb;35(2):394-400. doi: 10.1016/j.arth.2019.09.002. Epub 2019 Sep 7. PMID 31587982
• Bednar DA, Wong A, Farrokhyar F, Paul J. Dexamethasone Perioperative Coanalgesia in Lumbar Spine Fusion: A Controlled Cohort Study of Efficacy and Safety. J Spinal Disord Tech. 2015 Aug;28(7):E422-6. doi: 10.1097/BSD.0b013e3182a1ddd3. PMID 26213843

Идентификаторы

NCT: NCT06367855 · KSKC20222025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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