Efficacy of Epidural Steroid for Controlling Pain After P... | NCT02001259

Studies
Efficacy of Epidural Steroid for Controlling Pain After Primary TKA

NCT02001259

Sponsor

Thammasat University

Status

Completed

Last Update Posted

May 9, 2017Actual

Enrollment

108Actual

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

epidural triamsinolone
epidural lidocaine

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Jun 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Nov 27, 2013

First Submission Date that Met QC Criteria

Nov 27, 2013

First Posted Date

Dec 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2017

Last Update Posted Date

May 9, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epidural lidocaine	Active Comparator	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
epidural triamsinolone	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
epidural triamsinolone	Drug	add drugs into catheter at 48 hr after surgery	epidural triamsinolone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Supakit Kanitnate, M.D.	orthopaedic department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
department of orthopaedic surgery, Faculty of medicine, Thammasat university		Khlong Luang	Changwat Pathum Thani	066	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided