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The Effect of Combined Perioperative and Continuous Postoperative Corticosteroids Versus Single-Dose Perioperative Corticosteroids on Postoperative Pain in Degenerative Lumbar Spine Surgery: A Randomized controlled trial

The Effect of Combined Perioperative and Continuous Postoperative Corticosteroids Versus Single-Dose Perioperative Corticosteroids on Postoperative Pain in Degenerative Lumbar Spine Surgery: A Randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251231007
Enrollment
48
Registered
2025-12-31
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain following degenerative lumbar spine surgery Degenerative lumbar spine surgery Corticosteroid Postoperative pain Morphine consumption

Interventions

Dexamathasone 8 mg intravenously intraoperatively following by Dexamethasone 8 mg intravenously every 8 hours for total of 3 doses, postoperatively,Dexamathasone 8 mg intravenously intraoperatively fo
Experimental Drug,Placebo Comparator Drug
Continuous dexamethasone,Single-dose dexamethasone

Sponsors

Naresuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosed with degenerative lumbar spine disease and scheduled to undergo conventional laminectomy with instrumented fusion of 2-5 levels, performed by the spine surgery team and study investigators at Naresuan University Hospital. 2. Patients capable of using patient-controlled analgesia (PCA) and able to report pain intensity using the Numeric Rating Scale (NRS). 3. Patients who are willing to participate in the study and who provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presense of diabetes mellitus. 2. History of corticosteroid therapy prior to surgery, defined as a dose equivalent to prednisolone > 5 mg/day for more than 3 weeks before surgery, or > 20 mg/day. 3. Presence of spondylolisthesis greater than 50%, scoliosis greater than 20 degrees, or surgery performed primarily for spinal deformity correction. 4. History of prior spinal surgery at the same or adjacent levels. 5. History of spinal trauma or vertebral compression fracture prior to surgery. 6. History of malignancy involving the spine. 7. History of spinal infection, and the surgery is performed for infection control. 8. History of allergy to paracetamol, tramadol, NSAIDs, gabapentin, or bupivacaine.

Design outcomes

Primary

MeasureTime frame
Total morphine consumption every 8 hours postoperatively for 48 hours then every 24 hours until discharge Total cumulative morphine consumption (mg), recorded from the patient-controlled analgesia device and nursing records.

Secondary

MeasureTime frame
Rescue medication every 8 hours postoperatively for 48 hours then every 24 hours until discharge Name and frequency of non-opioids rescue analgesic doses administered, recorded by nurses,Numerical rating scale (NRS) every 8 hours postoperatively for 48 hours then every 24 hours until discharge 0-10 Numeric Rating Scale (NRS),Incidence of postoperative nausea and vomiting every 8 hours postoperatively for 48 hours then every 24 hours until discharge Incidence of postoperative nausea and/or vomiting, recorded by nurses,Time to first ambulation during hospitalization Time (hours) from end of surgery to first ambulation, recorded by physical therapists,Blood glucose every 24 hours for 72 hours Capillary blood glucose (mg/dL),C-reactive protein (CRP) every 24 hours for 72 hours Serum CRP level (mg/L),Oswestry Disability Index preoperative, postoperative 2 weeks, 1 months, 3 months Total score (0-100%), standardized questionnaire,Length of hospitalization until discharge Postoperative length of hospital stay (days),Surgical site infection postoperative 2 weeks, 1 months, 3 months Incidence of surgical site infection, assessed by the surgeon

Countries

Thailand

Contacts

Public ContactThanapong Kajhontrideth

Naresuan University Hospital

thanapong.kaj@gmail.com0909818159

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026