Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS®) Society recommendations.
Bertrand Debono, Thomas W Wainwright, Michael Y Wang...
https://pubmed.ncbi.nlm.nih.gov/33444664Actively Recruiting
Phase 4
Age: 50Years - 80Years
All Genders
Healthy Volunteers
ID06367855
Efficacy and Safety of Preemptive Intravenous Dexamethasone in Minimally Invasive Spine Fusion Surgery (MIS-TLIF)
Led by Potsawat Surabotsopon · Updated on 2025-09-08
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Dexamethasone given before minimally invasive spine fusion surgery (MIS-TLIF) to reduce postoperative back pain. This study aims to improve surgical outcomes with minimal side effects by comparing Dexamethasone to a placebo. The trial also investigates morphine use, side effects like nausea, infection rates, blood sugar levels, spinal fusion success, and hospital stay duration. Participants receive either an intravenous injection of Dexamethasone or a normal saline placebo before their MIS-TLIF surgery, which involves fusing 1-2 spinal levels using a less invasive technique. The study includes a randomized, quadruple-blind design comparing these two groups to assess the effectiveness and safety of preemptive Dexamethasone. During the study, back pain and medication use are measured at multiple points up to 12 weeks after surgery. Fusion rates are checked at 6 months, and hospital stay length is monitored for a year. Researchers will also track complications and adverse reactions to gather comprehensive data on recovery and safety. The total participation spans from surgery through a year of follow-up assessments.
CONDITIONS
Brief Title
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF
Who Can Participate
Age: 50Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age range: 50 to 80 years old
- Scheduled for minimally invasive spine fusion surgery (MIS TLIF) at 1-2 spinal levels
You will not qualify if you...
- Previous spine surgery
- HbA1C greater than or equal to 7.5 mg%
- Allergy to any study medication
- History of using systemic steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 day (surgery day)
Participants receive preemptive intravenous dexamethasone or normal saline before undergoing minimally invasive spine fusion surgery (MIS-TLIF).
1 treatment visit (in-person)
Post-operative Follow-up
Duration - Up to 12 weeks with additional assessments at 6 months and 1 year
Participants are monitored for pain, morphine use, side effects, surgical site infections, and recovery including fusion rates and hospital stay length.
Visits at 24 hours, 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year post surgery
Trial Site Locations
Total: 1 location
1
Thammasat university hospital
Pathum Thani, Changwat Pathum Thani, Thailand, 12120
Actively Recruiting
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Research Team
K
Konthorn Chankong, Master's degree
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF.
Ralph J Mobbs, Kevin Phan, Greg Malham...
https://pubmed.ncbi.nlm.nih.gov/27683674Comparative outcomes of minimally invasive surgery for posterior lumbar fusion: a systematic review.
Christina L Goldstein, Kevin Macwan, Kala Sundararajan...
https://pubmed.ncbi.nlm.nih.gov/24464507Transforaminal Lumbar Interbody Fusion: Traditional Open Versus Minimally Invasive Techniques.
Michael J Lee, James Mok, Pranay Patel
https://pubmed.ncbi.nlm.nih.gov/29337717Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature.
Angelo Salerno, Robert Hermann
https://pubmed.ncbi.nlm.nih.gov/16757774Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials.
Gildàsio S De Oliveira, Marcela D Almeida, Honorio T Benzon...
https://pubmed.ncbi.nlm.nih.gov/21799397Intravenous Dexamethasone Injection Reduces Pain From 12 to 21 Hours After Total Knee Arthroplasty: A Double-Blind, Randomized, Placebo-Controlled Trial.
Nattapol Tammachote, Supakit Kanitnate
https://pubmed.ncbi.nlm.nih.gov/31587982Dexamethasone Perioperative Coanalgesia in Lumbar Spine Fusion: A Controlled Cohort Study of Efficacy and Safety.
Drew A Bednar, Arthur Wong, Forough Farrokhyar...
https://pubmed.ncbi.nlm.nih.gov/26213843Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial.
Shiveindra B Jeyamohan, Tyler J Kenning, Karen A Petronis...
https://pubmed.ncbi.nlm.nih.gov/25932600