Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy (PregabaNeph)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility 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
Sites / Locations
- Medical University of Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Pregabalin group
Arm Description
Placebo
Receiving 300mg pregabalin preoperative
Outcomes
Primary Outcome Measures
postoperative opioid consumption
Secondary Outcome Measures
Full Information
NCT ID
NCT00957177
First Posted
August 11, 2009
Last Updated
May 26, 2011
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT00957177
Brief Title
Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy
Acronym
PregabaNeph
Official Title
Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Graz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Pregabalin group
Arm Type
Active Comparator
Arm Description
Receiving 300mg pregabalin preoperative
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
300mg pregabalin orally 1 hour before operation
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
postoperative opioid consumption
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Sandner-Kiesling, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helmar Bornemann-Cimenti, MD, DSc
Organizational Affiliation
Graz Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Links:
URL
http://www.medunigraz.at
Description
Medical University of Graz
Learn more about this trial
Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy
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