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Pain Treatment After TKA With LIA and Intra-articular Continuous Infusion Pump

NCT ID: NCT01726686

Last Updated: 2014-11-26

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to evaluate the effect on postoperative pain and function by adding intraarticular continuous infusion pump with local anesthetic after total knee arthroplasty where local infiltration analgesia has already been given.

Detailed Description

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200 patients with osteoarthritis (OA) of the knee necessitating total knee arthroplasty are entered into the study. All patients are given a standard protocol of analgesics pre- and postoperatively. All patients get periarticular LIA-injection (150 ml) with a total of 300 mg Ropivacaine, 30 mg Toradol and 0.5 mg Adrenalin. In the end of the operation all patients get an epidural type of catheter intraarticular with a coupled continuous infusion pump that delivers 2 ml per hour and are disconnected after 48 hours. The University hospital pharmacy has prepared 200 pumps; 100 Active substance pumps with 100 ml Ropivacaine (10mg/ml) and 100 placebo pumps with 100 ml sodium chloride (NaCl). All patients are by computer software randomized to receive either active or placebo pump. Only one nurse, not involved in neither the operation nor the after treatment, has the key to what substance it is in the numbered pumps. Thus, it is a double blinded trial during the whole follow up period. Before the operation the patients are asked to fill out a knee specific outcome questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), and a general outcome questionnaire, the Euroqol (EQ-5D), and the knee range of motion is measured by a physiotherapist. After the operation the patients are monitored at the ward by the nurses and physiotherapists. The level of pain is measured twice daily (noon and 8 PM) according to the Visual-Analog-Scale (VAS). The range of motion and is measured on day 4 and at the day 14 and day 30 follow up. The number of days the patients need to stay in hospital after operation are registered. The amount of extra doses of analgesics the patient requires are registered as well as the complications (illness, wound problems, infections etc). The patients are to be followed clinically for 2 years as well as with outcome questionnaires.

Conditions

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Postoperative Pain Management

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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Ropivacaine in the pump

The intra-articular Continuous Infusion Pump is filled with Ropivacaine,10 mg/ml, set at 2 ml/hour for 48 hours postoperatively.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour

Placebo in the pump

The intra-articular Continuous Infusion Pump is filled with NaCl, set at 2 ml/hour for 48 hours postoperatively.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ropivacaine

100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Naropin, Narop

Eligibility Criteria

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Inclusion Criteria

* Primary osteoarthritis of the knee necessitating total knee replacement
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria

* Known allergy to local anaesthetics or other contraindication for the use of local anaesthetics.
* Treatment with Warfarin.
* Bilateral operation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Gunnar Flivik

Associate Professor, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar Flivik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Orthopedics, Skane University Hospital, Lund University, Sweden

Locations

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Department of Orthopedics, Skane University Hospital, Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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LIA-Pump_AA

Identifier Type: -

Identifier Source: org_study_id