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Postoperative Analgesia After Total Knee Arthroplasty

NCT ID: NCT00421967

Last Updated: 2008-05-07

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-04-30

Brief Summary

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Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization.

The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee

Keywords

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Postoperative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Ropivacaine, Ketorolac, adrenaline

Intervention Type DRUG

Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac

2

Group Type ACTIVE_COMPARATOR

Ropivacaine Ketorolac

Intervention Type DRUG

Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg

Interventions

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Ropivacaine, Ketorolac, adrenaline

Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac

Intervention Type DRUG

Ropivacaine Ketorolac

Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients admitted consecutively to primary total knee arthroplasty.
* Provided informed consent

Exclusion Criteria

* Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
* Severe chronic neurogenic pain
* Medical treated diabetes
* Contraindications for spinal aesthesia and epidural analgesia
* Known hypersensitivity towards study drugs
* Rheumatoid arthritis
* Treatment with narcotics
* Treatment with antidepressants
* Severe obesity BMI\>35
* Treatment with antacid
* Not able to speak and understand Danish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Aarhus University Hospital

Principal Investigators

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Birgitte V Christensen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Glostrup Hospital, Glostrup 2600, Denmark

Locations

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Glostrup Hospital

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2006-004638-33.

Identifier Type: -

Identifier Source: org_study_id