Status:

COMPLETED

Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

Lead Sponsor:

Assiut University

Conditions:

Postoperative Pain Following Radical Cystectomy

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

PHASE3

Brief Summary

This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy.

Eligibility Criteria

Inclusion

  • Sixty patients between the ages of 18 and 60 years.
  • American Society of Anesthesiologists (ASA) I-II physical status.
  • undergoing radical cystectomy under general anesthesia.

Exclusion

  • Patients with a history of drug or alcohol abuse.
  • patients with chronic pain or daily intake of analgesics.
  • uncontrolled diabetes mellitus.
  • uncontrolled hypertension.
  • atherosclerotic heart disease.
  • seizures.
  • impaired kidney or liver functions,
  • patients with body mass index ≥35 kg/m2, and whom
  • patients that could not control a patient controlled analgesia (PCA) device.

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2015

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT02724293

Start Date

September 1 2014

End Date

November 1 2015

Last Update

March 31 2016

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Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy | DecenTrialz