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NCT04653415
Large Doses of Methylprednisolone Combined With Gabapentin in Total Knee Arthroplasty
Phase 4 trial testing Gabapentin 300mg in Arthroplasty Complications in 160 participants. Completed in 1 May 2020.
1 January 2020
Quick facts
| Lead sponsor | Jagiellonian University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 160 |
| Start date | 1 June 2019 |
| Primary completion | 1 January 2020 |
| Estimated completion | 1 May 2020 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Gabapentin 300mg — full drug profile →
- Methylprednisolone 125 mg — full drug profile →
- Tablet
- Normal Saline 10 mL Injection
Conditions studied
- Arthroplasty Complications — all drugs for Arthroplasty Complications →
- Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Perioperative Complication — all drugs for Perioperative Complication →
Sponsor
Jagiellonian University
Who can join
65 and older, any sex, with Arthroplasty Complications or Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study was to assess whether administration of gabapentin and methylprednisolone as "pre-emptive analgesia" in a group of patients above 65 years of age would be effective in complex pain management therapy following total knee arthroplasty (TKA). For the study investigators will qualify one hundred seventy, above 65 years old patients. The participants will be double-blind randomized into two groups: the study and controls The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone, while the others placebo. Perioperatively, all the patients will receive opioid and nonopioid analgesic agents calculated for 1 kg of body weight. Investigators will measure the levels of inflammatory markers (leukocytosis, C-reactive protein - CRP), pain intensity level at rest (numerical rating scale - NRS), the life parameters and all complications.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pre-emptive analgesia with methylprednisolone and gabapentin in total knee arthroplasty in the elderly.
Liszka H, Zając M, Gądek A. · · 2022 · cited 6× · PMID 35149701 · DOI 10.1038/s41598-022-05423-4
Verify or expand the search:
- PubMed search for NCT04653415
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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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 NCT04653415 (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 Jagiellonian University
- Last refreshed: 4 December 2020
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