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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957177
First Posted: August 12, 2009
Last Update Posted: May 27, 2011
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.
Information provided by:
Medical University of Graz
  Purpose

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 Intervention Phase
Postoperative Pain Drug: Pregabalin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

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

Estimated Enrollment: 20
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Other Name: Control
Active Comparator: Pregabalin group
Receiving 300mg pregabalin preoperative
Drug: Pregabalin
300mg pregabalin orally 1 hour before operation
Other Name: Lyrica

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00957177


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

Additional Information:
Responsible Party: Sandner-Kiesling Andreas, Prof. Dr., Medical Universitiy of Graz
ClinicalTrials.gov Identifier: NCT00957177     History of Changes
Other Study ID Numbers: PregabaNeph
First Submitted: August 11, 2009
First Posted: August 12, 2009
Last Update Posted: May 27, 2011
Last Verified: May 2011

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