Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 50 to 80

Preoperative IV dexamethasone to reduce pain after minimally invasive lumbar fusion (MIS-TLIF)

Official title: Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF

Run by Thammasat University Hospital · NCT06367855 · Data updated 2026-11-12

This trial will test whether a single intravenous dose of dexamethasone given before MIS-TLIF reduces postoperative back pain and opioid use in people aged 50–80 having 1–2 level lumbar fusion.

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Quick facts

PhasePhase 4
Study typeInterventional
Ages50 Years to 80 Years
SexAll
Enrollment60 (estimated)
SponsorThammasat University Hospital
Academic / other
Locations1 site (Pathum Thani, Changwat Pathum Thani)
StatusRecruiting
StartedMay 1, 2024
Main results expectedNovember 30, 2025
Study endsDecember 31, 2025
Registry record updatedSeptember 8, 2025
Trial IDNCT06367855 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 50–80 years old scheduled for 1–2 level MIS-TLIF who have not had prior spine surgery, do not have recent systemic steroid use, and have acceptable glycemic control (HbA1c below 7.5%).

Probably not a fit

Patients with prior spine surgery, a history of systemic steroid use, steroid allergy, or poorly controlled diabetes (HbA1c ≥ 7.5%) were excluded and are unlikely to be eligible or benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 4 trial compares a preoperative intravenous dose of dexamethasone with normal saline given before minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Participants are patients aged 50–80 undergoing MIS-TLIF at one or two spinal levels and who meet metabolic and medication-related eligibility criteria. Primary outcomes focus on postoperative back pain, with secondary outcomes including opioid (morphine) consumption and other recovery metrics. The design uses a preemptive single injection to test whether adding dexamethasone to standard ERAS medications can further reduce pain and shorten recovery.

Why it matters

Potential benefit: If successful, a single preoperative IV dose of dexamethasone could reduce postoperative back pain, lower opioid requirements, and shorten hospital stay after MIS-TLIF.

How similar studies have gone: Preoperative dexamethasone has demonstrated pain and opioid-sparing benefits in a variety of surgical settings, but evidence specific to preemptive IV use in MIS-TLIF is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Thammasat university hospital
    Pathum Thani, Changwat Pathum Thani, Thailand
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.