Health TrialsbyHealthPanel

Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF

ConditionsSpinal Stenosis LumbarDisc DegenerationDisc DiseaseFusion of SpineSurgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-80
SponsorPotsawat Surabotsopon

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age range: 50-80 years old.

Undergoing MIS TLIF surgery at 1-2 spinal levels.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    long-acting corticosteroid IV route

  • Normal saline

    Drug

    normal saline

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Dexamethasone groupActive comparator 1 intervention
Group B: Normal saline groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

effectiveness of dexamethasone

postoperative VAS score at rest and motion for back pain

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

Secondary outcomes

1

Morphine consumption

rate of morphine usage for pain management

Time frame
24 hours post operative period
2

Complication

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

Time frame
24 hours, 2 weeks, 6 weeks, 12 weeks post operative period
3

Fusion rate

To compare the fusion rates of the spinal bones

Time frame
6months
4

Length of hospital stay

To compare the length of hospital stays after surgery.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Potsawat Surabotsopon

Lead sponsor

Thammasat University Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now