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NCT Number: NCT06367855

Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat university hospital

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location status: Recruiting

Location contact

Konthorn Chankong, master

CONTACT

[email protected]

+66859496902

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Dexamethasone

Drug

long-acting corticosteroid IV route

normal saline

Drug

normal saline

Primary outcomes

  1. effectiveness of dexamethasone

    Time frame: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period

    postoperative VAS score at rest and motion for back pain

Secondary outcomes

  1. Morphine consumption

    Time frame: 24 hours post operative period

    rate of morphine usage for pain management

  2. Complication

    Time frame: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period

    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

  3. Fusion rate

    Time frame: 6months

    To compare the fusion rates of the spinal bones

  4. Length of hospital stay

    Time frame: 1 year

    To compare the length of hospital stays after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Konthorn Chankong, Master's degree

CONTACT

[email protected]

+66859496902

Sponsors and collaborators

Lead sponsor

Potsawat Surabotsopon

Other

Registry information

Acronym: MIS-TLIF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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