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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00957177
First received: August 11, 2009
Last updated: May 26, 2011
Last verified: May 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Sandner-Kiesling Andreas, Prof. Dr., Medical Universitiy of Graz
ClinicalTrials.gov Identifier: NCT00957177     History of Changes
Other Study ID Numbers: PregabaNeph
Study First Received: August 11, 2009
Last Updated: May 26, 2011
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 29, 2014