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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.
Surgery for spine fusion through a minimally invasive technique called MIS-TLIF has become increasingly popular nowadays due to various reasons such as lower blood loss and reduced need for blood transfusions, less postoperative back pain, and shorter surgical duration compared to the traditional technique known as TLIF. However, even after MIS TLIF, patients still experience issues such as wound or back pain, which can affect their physical activity and increase the risk of infection. Prolonged hospital stays lead to resource wastage.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone group | Active Comparator |
| |
| Normal saline group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | long-acting corticosteroid IV route |
| |
| Measure | Description | Time Frame |
|---|---|---|
| effectiveness of dexamethasone | postoperative VAS score at rest and motion for back pain | 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | rate of morphine usage for pain management | 24 hours post operative period |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konthorn Chankong, Master's degree | Contact | +66859496902 | gearkonthorn@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat university hospital | Recruiting | Pathum Thani | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33444664 | Background | 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. | |
| 27683674 |
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data request can be submitted 1 year after publication and available up to 2 years
data request can be submitted 1 year after publication and available up to 2 years
access to IPD can be requested to the first researcher's email as noted in this form
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Normal saline |
| Drug |
normal saline |
|
| 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period |
| Fusion rate | To compare the fusion rates of the spinal bones | 6months |
| Length of hospital stay | To compare the length of hospital stays after surgery. | 1 year |
| 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. |
| 24464507 | Result | 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. |
| 29337717 | Result | 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. |
| 16757774 | Result | 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. |
| 21799397 | Result | 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. |
| 31587982 | Result | 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. |
| 26213843 | Result | 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. |
| 25932600 | Result | 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. |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |