Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy

Phase 3

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT00957177
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-26
• Last Update Posted: 2011-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Pregabalin group	Pregabalin	Receiving 300mg pregabalin preoperative

Primary Outcome Measures

Name	Time	Method
postoperative opioid consumption	48 hours

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria