Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF
NCT ID: NCT06367855
Last Updated: 2025-09-08
Study Results
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Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2024-05-01
2025-12-31
Brief Summary
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Detailed Description
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In the Enhanced Recovery After Surgery (ERAS) program for spine surgery, preoperative medication, including Acetaminophen, NSAIDs, and Gabapentinoids, is recommended to alleviate postoperative back pain. However, even after implementing ERAS, patients undergoing MIS TLIF still experience pain, suggesting that further pain reduction strategies are needed. The use of Dexamethasone as preemptive medication has shown promising results in various surgeries, with minimal side effects and a manageable cost. Dexamethasone, administered via injection, has a longer duration of action compared to other steroids, making it suitable for preemptive use.
The main objective is to study the effectiveness of using Dexamethasone via intravenous injection before minimally invasive spine fusion surgery, known as MIS-TLIF, in reducing postoperative back pain.
The secondary objectives are to compare the rate of morphine usage for pain management after surgery between two groups.
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.
To compare the fusion rates of the spinal bones. To compare the length of hospital stays after surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexamethasone group
Dexamethasone
long-acting corticosteroid IV route
Normal saline group
Normal saline
normal saline
Interventions
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Dexamethasone
long-acting corticosteroid IV route
Normal saline
normal saline
Eligibility Criteria
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Inclusion Criteria
* Undergoing MIS TLIF surgery at 1-2 spinal levels.
Exclusion Criteria
* HbA1C greater than or equal to 7.5 mg%
* Allergic to all types of experimental medication.
* History of using systemic steroids.
50 Years
80 Years
ALL
Yes
Sponsors
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Potsawat Surabotsopon
OTHER
Responsible Party
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Potsawat Surabotsopon
MD
Locations
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Thammasat university hospital
Pathum Thani, Changwat Pathum Thani, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Mobbs RJ, Phan K, Malham G, Seex K, Rao PJ. Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF. J Spine Surg. 2015 Dec;1(1):2-18. doi: 10.3978/j.issn.2414-469X.2015.10.05.
Goldstein CL, Macwan K, Sundararajan K, Rampersaud YR. Comparative outcomes of minimally invasive surgery for posterior lumbar fusion: a systematic review. Clin Orthop Relat Res. 2014 Jun;472(6):1727-37. doi: 10.1007/s11999-014-3465-5.
Lee MJ, Mok J, Patel P. Transforaminal Lumbar Interbody Fusion: Traditional Open Versus Minimally Invasive Techniques. J Am Acad Orthop Surg. 2018 Feb 15;26(4):124-131. doi: 10.5435/JAAOS-D-15-00756.
Debono B, Wainwright TW, Wang MY, Sigmundsson FG, Yang MMH, Smid-Nanninga H, Bonnal A, Le Huec JC, Fawcett WJ, Ljungqvist O, Lonjon G, de Boer HD. Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Spine J. 2021 May;21(5):729-752. doi: 10.1016/j.spinee.2021.01.001. Epub 2021 Jan 12.
Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.
De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
Tammachote N, Kanitnate S. Intravenous Dexamethasone Injection Reduces Pain From 12 to 21 Hours After Total Knee Arthroplasty: A Double-Blind, Randomized, Placebo-Controlled Trial. J Arthroplasty. 2020 Feb;35(2):394-400. doi: 10.1016/j.arth.2019.09.002. Epub 2019 Sep 7.
Bednar DA, Wong A, Farrokhyar F, Paul J. Dexamethasone Perioperative Coanalgesia in Lumbar Spine Fusion: A Controlled Cohort Study of Efficacy and Safety. J Spinal Disord Tech. 2015 Aug;28(7):E422-6. doi: 10.1097/BSD.0b013e3182a1ddd3.
Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1.
Other Identifiers
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KSKC20222025
Identifier Type: -
Identifier Source: org_study_id
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