Efficacy of Epidural Steroid for Controlling Pain After Primary TKA

Overview

The purpose of this study is to determine efficacy of epidural steroid for postoperative pain control after TKA

Full Title of Study: “Efficacy of Epidural Steroid in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 2015

Detailed Description

Epidural triamsinolone can reduce postoperative pain and longer duration of pain control after TKA

Interventions

  • Drug: epidural triamsinolone
    • add drugs into catheter at 48 hr after surgery
  • Drug: epidural lidocaine
    • add into catheter at 48 hr after surgery

Arms, Groups and Cohorts

  • Active Comparator: Epidural lidocaine
    • epidural lidocaine: 3 mL of 1% lidocaine with adrenaline and 3 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery
  • Experimental: epidural triamsinolone
    • epidural triamsinolone: 40 mg of triamsinolone (1 mL), 2.5 mL of 1% lidocaine with adrenaline and 2.5 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery

Clinical Trial Outcome Measures

Primary Measures

  • post-operative pain
    • Time Frame: 3 months
    • measured with VAS for pain (VAS at rest and on motion)

Secondary Measures

  • functional knee score
    • Time Frame: 3 months
    • measured with WOMAC

Participating in This Clinical Trial

Inclusion Criteria

  • osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty – 50-85 years old – ASA class 1-3 Exclusion Criteria:

  • unable to perform epidural anaesthesia – history of drug allergies: lidocaine, steroid – renal impairment (CrCl <30 mL/min) – liver impairment – cognitive function disorders – displacement of epidural catheter

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Thammasat University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Supakit Kanitnate, orthopaedic department – Thammasat University
  • Overall Official(s)
    • Supakit Kanitnate, M.D., Principal Investigator, orthopaedic department

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