Local Infiltration Analgesia With Ropivacaine Versus Plac... | NCT00864409

Studies
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

NCT00864409

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Mar 18, 2009Estimated

Enrollment

12Estimated

Phase

Phase 4

Conditions

Postoperative Pain
Hip Arthroplasty

Interventions

ropivacaine 0,2%
saline.9%

Countries

Denmark

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

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 17, 2009

First Submission Date that Met QC Criteria

Mar 17, 2009

First Posted Date

Mar 18, 2009Estimated

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 17, 2009

Last Update Posted Date

Mar 18, 2009Estimated

Description Module

Brief Summary

High-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. In this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline (placebo) in the other hip.

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

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hip 1	Active Comparator	high volume local anesthetic infiltration	Drug: ropivacaine 0,2%
Hip 2	Placebo Comparator		Drug: saline.9%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ropivacaine 0,2%	Drug	Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL	Hip 1

Measure	Description	Time Frame
postoperative pain		0-48 hours postoperative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

scheduled for bilateral total hip arthroplasty
able to speak and understand Danish

Exclusion Criteria:

treatment with opioids or steroids

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lasse Andersen, MD	Contact	+45 36323632		lasse.oestergaard.andersen@hvh.regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hviovre University Hospital	Recruiting	Hvidovre		DK-2650	Denmark

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