CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 160 enrolled
Drug / intervention
Gabapentin 300mg +3 moredrug
Likely dose
Gabapentin 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04653415
NCT04653415Phase 4Completed
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The Impact of Pre-emptive Large Doses of Methylprednisolone Combined With Gabapentin on Pain Treatment and Convalescence After Total Knee Arthroplasty in Elderly: A Double-blind Randomized Study

Jagiellonian University·interventional·Posted Dec 4, 2020·Updated Dec 4, 2020

In Brief

A Phase 4 clinical trial evaluating Gabapentin 300mg, Methylprednisolone 125 mg, and 2 other interventions for Arthroplasty Complications and 3 related conditions. Completed, enrolled 160 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthroplasty Complications, Knee Osteoarthritis, Pain, Postoperative, Perioperative Complication
CountriesPoland
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedDec 4, 2020
Enrollment StartJun 1, 2019
Primary CompletionJan 1, 2020
Study CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.6 years ago

Interventions

Gabapentin 300mgdrug

The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone.

Methylprednisolone 125 mgdrug

The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone.

Tabletdrug

The controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - normal saline solution

Normal Saline 10 mL Injectiondrug

The controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - normal saline solution