Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy

NCT ID: NCT00957177

Last Updated: 2011-05-27

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

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-12-31

Brief Summary

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Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented.

Hyperalgesia is measured by von-Frey-Filaments.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Pregabalin group

Receiving 300mg pregabalin preoperative

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

300mg pregabalin orally 1 hour before operation

Interventions

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Pregabalin

300mg pregabalin orally 1 hour before operation

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Lyrica Control

Eligibility Criteria

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Inclusion Criteria

* patients undergoing elective nephrectomy

Exclusion Criteria

* contraindication against pregabalin
* creatinine \> 2.0 mg/dl
* GGT \>165, AST \>105, ALT \>135
* peptic Ulcus
* haemorrhagic diathesis
* angina pectoris, myocardial infarction
* stroke
* bronchial asthma
* opioid abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Medical Universitiy of Graz

Principal Investigators

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Andreas Sandner-Kiesling, MD

Role: STUDY_CHAIR

Medical University of Graz

Helmar Bornemann-Cimenti, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

Graz Medical University

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Related Links

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http://www.medunigraz.at

Medical University of Graz

Other Identifiers

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PregabaNeph

Identifier Type: -

Identifier Source: org_study_id

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