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Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

NCT ID: NCT00968955

Last Updated: 2011-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty.

The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.

Detailed Description

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In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.

Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Local infiltration with ropivacaine

Local infiltration with ropivacaine 0,2% (150 ML)

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Local infiltration with ropivacaine 0,2% (150 ML)

Local infiltration with saline

Local infiltration with saline (150 ML) (placebo)

Group Type PLACEBO_COMPARATOR

Ropivacaine

Intervention Type DRUG

Local infiltration with ropivacaine 0,2% (150 ML)

Interventions

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Ropivacaine

Local infiltration with ropivacaine 0,2% (150 ML)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective total hip arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria

* Alcohol or medical abuse
* Allergies to local anesthetics
* Age \< 18 years
* Daily use of opioids or glucocorticoids
* Pregnancy or breastfeeding
* Opioid intolerance
* Obesity defined as BMI\>40 kg/m2
* Diabetic neuropathy and rheumatoid arthritis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lundbeck Foundation

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Troels Haxholdt Lunn

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre University Hospital

Copenhagen, Hvidover, Denmark

Site Status

Hørsholm Hospital

Hørsholm, Hørsholm, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2009-41-3785

Identifier Type: -

Identifier Source: secondary_id

H-2-2009-079

Identifier Type: -

Identifier Source: org_study_id