Trial intelligence / Profile preview

Pre-emptive Gabapentin and Methylprednisolone for Pain After TKA

NCT04653415Phase 4

Key facts

Status: Completed
Start: Jun 2019
Primary completion: Jan 2020
Countries: 1
Sponsor: Jagiellonian University
Modality: Orthosteric Ligands

Drugs: gabapentinmethylprednisolone injection
Conditions: postoperative pain

Overview

Phase 4, randomised, double-blind trial of gabapentin and methylprednisolone injection in postoperative pain (2 arms), sponsored by Jagiellonian University. Primary endpoints: Pain intensity assessed by Numerical Rating Scale, Dose of parenteral analgesics agents at 24 hours and 3 more. Started Jun 2019; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Study Group
Gabapentin 300 mg PO + Methylprednisolone 125 mg IV single dose
Controls Group
Placebo PO + Saline IV single dose

Who it enrols

Patients over 65 years old undergoing unilateral total knee arthroplasty. Excludes patients with diabetes (type 1 or 2), elevated CRP, chronic steroid use, recent peptic ulcers, or chronic pain requiring high-intensity opioids.

Endpoints

Primary

Pain intensity assessed by Numerical Rating ScaleDay 0 (every 6 hours)
Dose of parenteral analgesics agents24 hours
C-reactive protein levelDay 3
Leukocytosis levelDay 3
Adverse effectsDay 14

Secondary

Duration of femoral nerve blockadeDay 0
Blood glucose levelDay 3

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