Use of Local Infiltration Analgesia Following Total Hip Arthroplasty

NCT ID: NCT01344395

Last Updated: 2013-01-23

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

Brief Summary

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The primary aim of this study is to evaluate if multiple postoperative administrations with a solution of ropivacaine, ketorolac and epinephrine into the operating field through a catheter would affect morphine consumption. Secondary end-points are pain intensity, side effects and length of stay.

Detailed Description

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Conditions

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Pain, Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RK-group

Group Type EXPERIMENTAL

ropivacaine and ketorolac

Intervention Type DRUG

The RK-group receives four intra-articular injections via catheter with a total volume of 40 ml (380 mg ropivacaine and 60 mg ketorolac) combined with 4 intravenous injections of saline during 24 hours postoperatively

K-group

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

The K-group receives four intra-articular injections via catheter with a total volume of 40 ml saline combined with 4 intravenous injections of ketorolac (total 60 mg) during 24 hours postoperatively

Interventions

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ropivacaine and ketorolac

The RK-group receives four intra-articular injections via catheter with a total volume of 40 ml (380 mg ropivacaine and 60 mg ketorolac) combined with 4 intravenous injections of saline during 24 hours postoperatively

Intervention Type DRUG

Ketorolac

The K-group receives four intra-articular injections via catheter with a total volume of 40 ml saline combined with 4 intravenous injections of ketorolac (total 60 mg) during 24 hours postoperatively

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for total hip arthroplasty
* Patients \> 18 years of age
* Signed written informed consent
* Spinal anaesthesia

Exclusion Criteria

* Allergy towards study drugs
* Rheumatoid arthritis
* Body Mass Index \> 35 (severe obesity)
* Pregnancy or nursing women
* Regular opioid use
* Patients who can not read or understand danish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lundbeck Foundation

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kjeld Søballe, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2009-016445-25

Identifier Type: -

Identifier Source: org_study_id

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