Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF

NCT06367855 | Recruiting Phase 4 DMC

• 1 other identifier: KSKC20222025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Stenosis Lumbar; Disc Degeneration; Disc Disease; Fusion of Spine; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Morphine consumption

  24 hours post operative period

• Complication

  24 hours, 2 weeks, 6 weeks, 12 weeks post operative period

• Fusion rate

  6months

• Length of hospital stay

  1 year

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

Drug: Dexamethasone

Normal saline group

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Dexamethasone DRUG

long-acting corticosteroid IV route

Dexamethasone group

Normal saline DRUG

normal saline

Normal saline group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 50-80 years old.
• Undergoing MIS TLIF surgery at 1-2 spinal levels.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Potsawat Surabotsopon: lead

Study Sites (1)

Thammasat university hospital

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

RECRUITING

Related Publications (9)

• 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.

  PMID: 27683674 BACKGROUND

• 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.

  PMID: 24464507 BACKGROUND

• 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.

  PMID: 29337717 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.

  PMID: 33444664 BACKGROUND

• 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.

  PMID: 16757774 BACKGROUND

• 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.

  PMID: 21799397 BACKGROUND

• 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.

  PMID: 31587982 BACKGROUND

• 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.

  PMID: 26213843 BACKGROUND

• 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.

  PMID: 25932600 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Konthorn Chankong, Master's degree

CONTACT

+66859496902; gearkonthorn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 16, 2024
• Study Start: May 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: data request can be submitted 1 year after publication and available up to 2 years
• Access Criteria: access to IPD can be requested to the first researcher's email as noted in this form

Locations

TH (1)