Efficacy of Epidural Steroid for Controlling Pain After Primary TKA

May 4, 2017 updated by: Supakit Kanitnate, Thammasat University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Khlong Luang, Pathumthani, Thailand, 066
        • department of orthopaedic surgery, Faculty of medicine, Thammasat university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: epidural lidocaine
add into catheter at 48 hr after surgery
Other Names:
  • epidural xylocaine
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
Drug: epidural triamsinolone
add drugs into catheter at 48 hr after surgery
Other Names:
  • epidural steroid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional knee score
Time Frame: 3 months
measured with WOMAC
3 months

Other Outcome Measures

Outcome Measure
Time Frame
complication of epidural triamcinolone
Time Frame: 2 weeks
2 weeks
range of motion of the knee
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: supakit kanitnate, M.D., Orthopaedic Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • orthoTU05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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