Intravenous 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/31587982/Actively Recruiting
Led by Potsawat Surabotsopon · Updated on 2025-09-08
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
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
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF
K
Konthorn Chankong, Master's degree
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Potsawat Surabotsopon
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor