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Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy (PregabaNeph)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957177
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : May 27, 2011
Information provided by:
Medical University of Graz

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Pregabalin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
Other Name: Control

Active Comparator: Pregabalin group
Receiving 300mg pregabalin preoperative
Drug: Pregabalin
300mg pregabalin orally 1 hour before operation
Other Name: Lyrica

Primary Outcome Measures :
  1. postoperative opioid consumption [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00957177

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Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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Study Chair: Andreas Sandner-Kiesling, MD Medical University of Graz
Principal Investigator: Helmar Bornemann-Cimenti, MD, DSc Graz Medical University

Additional Information:
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Responsible Party: Sandner-Kiesling Andreas, Prof. Dr., Medical Universitiy of Graz Identifier: NCT00957177     History of Changes
Other Study ID Numbers: PregabaNeph
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs