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OpenTrials
Completed

NCT Number: NCT02724293

Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

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

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Key information

Conditions

Postoperative Pain Following Radical Cystectomy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

pregabaline 300 mg once.

Drug

patients received pregabaline 300 mg 2 hours pre-operatively.

pregabaline 300 mg twice.

Drug

patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later.

pregabaline 600 mg once.

Drug

patients received pregabaline 600 mg 2 hours pre-operatively.

Placebo

Drug

patients received placebo

Primary outcomes

  1. visual analogue scale (VAS) score

    Time frame: 24 hours postoperatively

    analgesic efficacy of study drugs as represented by the VAS score of the patients in the first 24 hours.

  2. postoperative opioid consumption

    Time frame: 24 hours postoperatively

    ability of study drugs to reduce the postoperative opioid analgesic consumption.

  3. time to first request of opioid analgesia

    Time frame: 24 hours postoperatively

    ability of the study drugs to delay the request of rescue opioid analgesia.

Secondary outcomes

  1. Safety assessed by incidence of side effects

    Time frame: 24 hours postoperatively

    represented by the incidence of side effects during the follow up period of 24 hours.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Analgesic Efficacy and Safety of Peri-operative Pregabalin Following Radical Cystectomy, a Prospective,Randomized, Double-blinded, Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2016
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.