Back to resultsEfficacy of Epidural Steroid for Controlling Pain After Primary TKA
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
epidural triamsinolone
epidural lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring post-operative pain control, total knee arthroplasty, epidural steroid injection
Eligibility Criteria
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
Sites / Locations
- department of orthopaedic surgery, Faculty of medicine, Thammasat university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Epidural lidocaine
epidural triamsinolone
Arm Description
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: 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
Outcomes
Primary Outcome Measures
post-operative pain
measured with VAS for pain (VAS at rest and on motion)
Secondary Outcome Measures
functional knee score
measured with WOMAC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02001259
Brief Title
Efficacy of Epidural Steroid for Controlling Pain After Primary TKA
Official Title
Efficacy of Epidural Steroid in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
post-operative pain control, total knee arthroplasty, epidural steroid injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural lidocaine
Arm Type
Active Comparator
Arm Description
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
Arm Title
epidural triamsinolone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
epidural triamsinolone
Other Intervention Name(s)
epidural steroid
Intervention Description
add drugs into catheter at 48 hr after surgery
Intervention Type
Drug
Intervention Name(s)
epidural lidocaine
Other Intervention Name(s)
epidural xylocaine
Intervention Description
add into catheter at 48 hr after surgery
Primary Outcome Measure Information:
Title
post-operative pain
Description
measured with VAS for pain (VAS at rest and on motion)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
functional knee score
Description
measured with WOMAC
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
complication of epidural triamcinolone
Time Frame
2 weeks
Title
range of motion of the knee
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Supakit Kanitnate, M.D.
Organizational Affiliation
orthopaedic department
Official's Role
Principal Investigator
Facility Information:
Facility Name
department of orthopaedic surgery, Faculty of medicine, Thammasat university
City
Khlong Luang
State/Province
Pathumthani
ZIP/Postal Code
066
Country
Thailand
12. IPD Sharing Statement
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Efficacy of Epidural Steroid for Controlling Pain After Primary TKA
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