Efficacy of Epidural Steroid for Controlling Pain After Primary TKA

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: epidural lidocaine; Drug: epidural triamsinolone

• Registration Number: NCT02001259
• Lead Sponsor: Thammasat University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-04
• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural lidocaine	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
epidural triamsinolone	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

Primary Outcome Measures

Name	Time	Method
post-operative pain	3 months	measured with VAS for pain (VAS at rest and on motion)

Secondary Outcome Measures

Name	Time	Method
functional knee score	3 months	measured with WOMAC

Trial Locations

Locations (1)

department of orthopaedic surgery, Faculty of medicine, Thammasat university; 🇹🇭 Khlong Luang, Pathumthani, Thailand