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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

Primary Purpose

Postoperative Pain, Hip Arthroplasty

Status

Unknown status

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

ropivacaine 0,2%

saline.9%

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, total hip arthroplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

treatment with opioids or steroids

Sites / Locations

Hviovre University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hip 1

Hip 2

Arm Description

high volume local anesthetic infiltration

Outcomes

Primary Outcome Measures

postoperative pain

Secondary Outcome Measures

Full Information

NCT ID

NCT00864409

First Posted

March 17, 2009

Last Updated

March 17, 2009

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00864409

Brief Title

Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Hip Arthroplasty

Keywords

postoperative pain, total hip arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hip 1

Arm Type

Active Comparator

Arm Description

high volume local anesthetic infiltration

Arm Title

Hip 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ropivacaine 0,2%

Intervention Description

Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL

Intervention Type

Drug

Intervention Name(s)

saline.9%

Intervention Description

Wound infiltration with 170 mL sterile saline

Primary Outcome Measure Information:

Title

postoperative pain

Time Frame

0-48 hours postoperative

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: scheduled for bilateral total hip arthroplasty able to speak and understand Danish Exclusion Criteria: treatment with opioids or steroids

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lasse Andersen, MD

Phone

+45 36323632

lasse.oestergaard.andersen@hvh.regionh.dk

Facility Information:

Facility Name

Hviovre University Hospital

City

Hvidovre

ZIP/Postal Code

DK-2650

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lasse Andersen, MD

Phone

+45 36323632

lasse.oestergaard.andersen@hvh.regionh.dk

12. IPD Sharing Statement

Learn more about this trial

Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

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