Efficacy of Epidural Steroid for Controlling Pain After Primary TKA
Efficacy of Epidural Steroid in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
1 other identifier
interventional
108
1 country
1
Brief Summary
The purpose of this study is to determine efficacy of epidural steroid for postoperative pain control after TKA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 postoperative-pain
Started Jan 2014
Typical duration for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 9, 2017
May 1, 2017
1.4 years
November 27, 2013
May 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-operative pain
measured with VAS for pain (VAS at rest and on motion)
3 months
Secondary Outcomes (1)
functional knee score
3 months
Other Outcomes (2)
complication of epidural triamcinolone
2 weeks
range of motion of the knee
3 months
Study Arms (2)
Epidural lidocaine
ACTIVE COMPARATORepidural 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
EXPERIMENTALepidural 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
Interventions
add drugs into catheter at 48 hr after surgery
add into catheter at 48 hr after surgery
Eligibility Criteria
You may qualify if:
- osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- years old
- ASA class 1-3
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
department of orthopaedic surgery, Faculty of medicine, Thammasat university
Khlong Luang, Changwat Pathum Thani, 066, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Supakit Kanitnate, M.D.
orthopaedic department
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- orthopaedic department
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 4, 2013
Study Start
January 1, 2014
Primary Completion
June 1, 2015
Study Completion
October 1, 2015
Last Updated
May 9, 2017
Record last verified: 2017-05