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NCT05478382
Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery
Phase 4 trial testing Pregabalin 25 MG in Postoperative Pain in 132 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | Ajou University School of Medicine |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 1 October 2022 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
Drugs / interventions tested
- Pregabalin 25 MG — full drug profile →
- Placebo
Conditions studied
- Postoperative Pain — all drugs for Postoperative Pain →
- Pregabalin — all drugs for Pregabalin →
- Spine Surgery — all drugs for Spine Surgery →
- Adverse Reaction to Pregabalin — all drugs for Adverse Reaction to Pregabalin →
Sponsor
Ajou University School of Medicine
Who can join
18 and older, any sex, with Postoperative Pain or Pregabalin. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pain intensity
Time frame: Arrival at the general ward
Change of Visual analogue scale (VAS) pain score -
Pain intensity
Time frame: 6hours after surgery
Change of Visual analogue scale (VAS) pain score -
Pain intensity
Time frame: 24hours after surgery
Change of Visual analogue scale (VAS) pain score -
Pain intensity
Time frame: 48hours after surgery
Change of Visual analogue scale (VAS) pain score -
Pain intensity
Time frame: 72hours after surgery
Change of Visual analogue scale (VAS) pain score -
IV PCA usage
Time frame: Arrival at the general ward
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Sponsor's own description
The objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pregabalin as an effective treatment for acute postoperative pain following spinal surgery without major side effects: protocol for a prospective, randomized controlled, double-blinded trial.
Park KH, Chung NS, Chung HW, Kim TY, et al · · 2023 · cited 1× · PMID 37349841 · DOI 10.1186/s13063-023-07438-2
Verify or expand the search:
- PubMed search for NCT05478382
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Postoperative Pain
Currently open trials in the same condition.
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Other Ajou University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05478382 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ajou University School of Medicine
- Last refreshed: 26 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05478382.
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