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Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia

NCT ID: NCT01631799

Last Updated: 2012-06-29

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

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-12-31

Brief Summary

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Total knee replacement is very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Both methods are used in Germany. Both methods have advantages and disadvantages. We wanted to answer the question which method of analgesia - after total knee replacement - is better concerning complications and function (after 3 months) ?

Detailed Description

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Conditions

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Morbidity Mortality Complications Function

Keywords

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epidural anesthesia femoral block patient control analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Femoral Block

One group received a femoral block for analgesia after surgery. Ropivacain was administered continuously for three days.

Group Type ACTIVE_COMPARATOR

Femoral catheter

Intervention Type DEVICE

Femoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured.

Epidural Analgesia

One group received an epidural analgesia after surgery for three days.

Group Type ACTIVE_COMPARATOR

Epidural catheter

Intervention Type DEVICE

The epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured.

Interventions

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Femoral catheter

Femoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured.

Intervention Type DEVICE

Epidural catheter

The epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age 18 -80 years
* ASA I-III
* Surgery: total knee replacement
* informed consent

Exclusion Criteria

* obesity
* contraindication for epidural anesthesia
* coagulation disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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Thomas Mencke

PD Dr. Thomas Mencke

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Mencke, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Anesthesia, University of Rostock

Locations

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University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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A 40 2008

Identifier Type: -

Identifier Source: org_study_id