Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

NCT ID: NCT00562627

Last Updated: 2011-08-08

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-07-31

Brief Summary

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Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

The aim of this study is to:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Detailed Description

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Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Conditions

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Osteoarthritis of the Knee

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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LIA IV

Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine

Group Type EXPERIMENTAL

ropivacaine

Intervention Type DRUG

intraoperative and 1. postoperative day

adrenaline

Intervention Type DRUG

intraoperative LIA (IV and IA) and continuous EDA

ketorolac

Intervention Type DRUG

intraoperative and 1. postoperative day

morphine

Intervention Type DRUG

intraoperative

LIA IA

Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine

Group Type EXPERIMENTAL

ropivacaine

Intervention Type DRUG

intraoperative and 1. postoperative day

adrenaline

Intervention Type DRUG

intraoperative LIA (IV and IA) and continuous EDA

ketorolac

Intervention Type DRUG

intraoperative and 1. postoperative day

morphine

Intervention Type DRUG

intraoperative

EDA

standard continuous epidural analgesia

Group Type ACTIVE_COMPARATOR

adrenaline

Intervention Type DRUG

intraoperative LIA (IV and IA) and continuous EDA

fentanyl

Intervention Type DRUG

continuous postoperatively

bupivacaine

Intervention Type DRUG

continuous postoperatively

Interventions

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ropivacaine

intraoperative and 1. postoperative day

Intervention Type DRUG

adrenaline

intraoperative LIA (IV and IA) and continuous EDA

Intervention Type DRUG

ketorolac

intraoperative and 1. postoperative day

Intervention Type DRUG

morphine

intraoperative

Intervention Type DRUG

fentanyl

continuous postoperatively

Intervention Type DRUG

bupivacaine

continuous postoperatively

Intervention Type DRUG

Other Intervention Names

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Naropin Adrenalin (epinephrine) Toradol Morfin Marcain

Eligibility Criteria

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Inclusion Criteria

* patients at least 18 years of age
* scheduled for elective total knee arthroplasty
* ASA I-III
* signed written informed consent

Exclusion Criteria

* age \< 18
* ASA \> III
* moderate or severe cardiac disease, bronchial asthma
* allergy against ropivacaine, ketorolac or morphine
* analgetic abuse
* pregnancy or nursing women
* severe psychiatric disease
* moderate to severe dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asker & Baerum Hospital

OTHER

Sponsor Role lead

Responsible Party

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Asker and Baerum Hospital

Principal Investigators

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Ulrich J Spreng, MD

Role: PRINCIPAL_INVESTIGATOR

Asker and Baerum Hospital

Locations

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Asker and Baerum Hospital

Rud, , Norway

Site Status

Countries

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Norway

References

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Spreng UJ, Dahl V, Hjall A, Fagerland MW, Raeder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. doi: 10.1093/bja/aeq232. Epub 2010 Aug 24.

Reference Type DERIVED
PMID: 20736233 (View on PubMed)

Other Identifiers

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EudraCT 2007-003030-41

Identifier Type: -

Identifier Source: secondary_id

REK 1.2007.1603

Identifier Type: -

Identifier Source: secondary_id

2007-003030-41

Identifier Type: -

Identifier Source: org_study_id

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