Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic

NCT ID: NCT00927225

Last Updated: 2009-06-24

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-06-30

Brief Summary

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Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee arthroplasty in 16 patients undergoing bilateral knee arthroplasty.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active

subcutaneous wound infiltration with 50 mL ropivacaine 0.2%

Group Type ACTIVE_COMPARATOR

ropivacaine 0.2%, 50 mL

Intervention Type DRUG

placebo

subcutaneous wound infiltration with 50 mL saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Interventions

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ropivacaine 0.2%, 50 mL

Intervention Type DRUG

normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* total bilateral knee arthroplasty

Exclusion Criteria

* immunological diseases
* treatment with opioids or steroids
* allergy to any drugs administered
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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Hvidovre Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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Andersen LO, Husted H, Kristensen BB, Otte KS, Gaarn-Larsen L, Kehlet H. Analgesic efficacy of subcutaneous local anaesthetic wound infiltration in bilateral knee arthroplasty: a randomised, placebo-controlled, double-blind trial. Acta Anaesthesiol Scand. 2010 May;54(5):543-8. doi: 10.1111/j.1399-6576.2009.02196.x. Epub 2010 Jan 6.

Reference Type DERIVED
PMID: 20055763 (View on PubMed)

Other Identifiers

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H-D-2008-104

Identifier Type: -

Identifier Source: org_study_id

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