NCT00957177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3 postoperative-pain

Timeline
Completed

Started Apr 2009

Typical duration for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 27, 2011

Status Verified

May 1, 2011

Enrollment Period

1.7 years

First QC Date

August 11, 2009

Last Update Submit

May 26, 2011

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative opioid consumption

    48 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Pregabalin group

ACTIVE COMPARATOR

Receiving 300mg pregabalin preoperative

Drug: Pregabalin

Interventions

PregabalinDRUG

300mg pregabalin orally 1 hour before operation

Also known as: Lyrica
Pregabalin group
PlaceboDRUG

Placebo

Also known as: Control
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective nephrectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Andreas Sandner-Kiesling, MD

    Medical University of Graz

    STUDY CHAIR

  • Helmar Bornemann-Cimenti, MD, DSc

    Graz Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 12, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 27, 2011

Record last verified: 2011-05

Locations

AU(1)