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NCT00957177 Clinical Trial

Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy

Postoperative Pain Clinical Trial

— PregabaNeph  

Official title:
Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00957177
Other study ID # PregabaNeph
Secondary ID
Status Completed
Phase Phase 3
First received August 11, 2009
Last updated May 26, 2011
Start date April 2009
Est. completion date December 2010

Study information
Verified date May 2011
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin
300mg pregabalin orally 1 hour before operation
• Placebo
Placebo

Locations
Country Name City State
Austria Medical University of Graz Graz

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative opioid consumption 48 hours No
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