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Large Doses of Methylprednisolone Combined With Gabapentin in Total Knee Arthroplasty

NCT04653415 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-12-04

No results posted yet for this study

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.

Conditions

  • Arthroplasty Complications
  • Knee Osteoarthritis
  • Pain, Postoperative
  • Perioperative Complication

Interventions

DRUG

Gabapentin 300mg

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

DRUG

Methylprednisolone 125 mg

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

DRUG

Tablet

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

DRUG

Normal Saline 10 mL Injection

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

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-01-01
Completion
2020-05-01

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653415 on ClinicalTrials.gov