Pain Control After Total Knee Arthroplasty | NCT03032133

Studies
Pain Control After Total Knee Arthroplasty

NCT03032133

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Feb 12, 2019Actual

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

Regional pain control
Local pain control

Countries

Germany

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

Feb 2019

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

Feb 2016Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2018Actual

First Submitted Date

Jan 24, 2017

First Submission Date that Met QC Criteria

Jan 24, 2017

First Posted Date

Jan 26, 2017Estimated

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

Feb 11, 2019

Last Update Posted Date

Feb 12, 2019Actual

Name	Class
Mathys Ltd Bettlach	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regional pain control	Active Comparator	Regional pain catheter	Procedure: Regional pain control
Local pain control	Experimental	Local intraarticular pain catheter	Procedure: Local pain control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regional pain control	Procedure	Regional pain catheter	Regional pain control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	Pain on Visual Analog Scale	daily until day 7 after surgery

Secondary Outcomes

Measure	Description	Time Frame
analgetics	Use of additional analgetics	daily until day 7 after surgery
Mobility	grade of mobility	daily until day 7 after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication to Total Knee Arthroplasty
Signed informed consent

Exclusion Criteria:

Chronic pain
Allergy against local anaesthetics
Not understanding study or questionnaires

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jörg Lützner, MD	TU Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Carl Gustav Carus		Dresden		01307	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010146	Pain

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided