Continuous Versus Intermittent Sciatic Block for Total Kn... | NCT01843153

Studies
Continuous Versus Intermittent Sciatic Block for Total Knee Arthroplasty

NCT01843153

Sponsor

Kreiskrankenhaus Dormagen

Status

Completed

Last Update Posted

Mar 31, 2015Estimated

Enrollment

140Actual

Phase

Phase 4

Conditions

Total Knee Arthroplasty
Pain

Interventions

Ropivacaine

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

Apr 2013

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

Apr 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 25, 2013

First Submission Date that Met QC Criteria

Apr 29, 2013

First Posted Date

Apr 30, 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

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 role of a sciatic block in addition to a femoral block remains controversial. The study addresses this topic by comparing a continuous block versus an injection on demand.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intermittent	Other	injection of ropivacaine on demand	Drug: Ropivacaine
continuous	Other	continuous ropivacaine infusion	Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug		continuous intermittent

Measure	Description	Time Frame
pain score (VRS)		4 days

Measure	Description	Time Frame
frequency of injections into the sciatic catheter		4 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for total knee arthroplasty

Exclusion Criteria:

failure to establish femoral and sciatic block
insufficient analgesic effect of the block
patient declines to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KKH Dormagen		Dormagen		D-51375	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26810904	Derived	Soltesz S, Meiger D, Milles-Thieme S, Saxler G, Ziegeler S. Intermittent versus continuous sciatic block combined with femoral block for patients undergoing knee arthroplasty. A randomized controlled trial. Int Orthop. 2016 Sep;40(9):1861-7. doi: 10.1007/s00264-016-3117-3. Epub 2016 Jan 25.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds