Preoperative IV dexamethasone to reduce pain after minimally invasive lumbar fusion (MIS-TLIF)
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF
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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Thammasat University Hospital Academic / other |
| Locations | 1 site (Pathum Thani, Changwat Pathum Thani) |
| Trial ID | NCT06367855 on ClinicalTrials.gov |
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.
Who should consider this trial
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%).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pathum Thani, Changwat Pathum Thani
- Thammasat university hospital — Pathum Thani, Changwat Pathum Thani, Thailand (Recruiting)
Study contacts
- Study coordinator: Konthorn Chankong, Master's degree
- Email: gearkonthorn@gmail.com
- Phone: +66859496902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.