Surgery Clinical Trial
— MIS-TLIFOfficial title:
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control 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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 31, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Potsawat Surabotsopon |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. E — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effectiveness of dexamethasone | postoperative VAS score at rest and motion for back pain | 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period | |
Secondary | Morphine consumption | rate of morphine usage for pain management | 24 hours post operative period | |
Secondary | 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 | 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period | |
Secondary | Fusion rate | To compare the fusion rates of the spinal bones | 6months | |
Secondary | Length of hospital stay | To compare the length of hospital stays after surgery. | 1 year |
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