search
Back to results

Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

Primary Purpose

Postoperative Pain Following Radical Cystectomy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pregabaline 300 mg once.
pregabaline 300 mg twice.
pregabaline 600 mg once.
placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Following Radical Cystectomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group I (placebo)

    Group II (pregabaline 300 once)

    Group III (pregabaline 300 twice)

    Group IV (pregabaline 600)

    Arm Description

    patients received placebo.

    patients received pregabalin 300 mg 2 hours preoperatively.

    patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose.

    patients received pregabalin 600 mg 2 hours preoperatively

    Outcomes

    Primary Outcome Measures

    visual analogue scale (VAS) score
    analgesic efficacy of study drugs as represented by the VAS score of the patients in the first 24 hours.
    postoperative opioid consumption
    ability of study drugs to reduce the postoperative opioid analgesic consumption.
    time to first request of opioid analgesia
    ability of the study drugs to delay the request of rescue opioid analgesia.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 25, 2016
    Last Updated
    March 30, 2016
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02724293
    Brief Title
    Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy
    Official Title
    Analgesic Efficacy and Safety of Peri-operative Pregabalin Following Radical Cystectomy, a Prospective,Randomized, Double-blinded, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain Following Radical Cystectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I (placebo)
    Arm Type
    Placebo Comparator
    Arm Description
    patients received placebo.
    Arm Title
    Group II (pregabaline 300 once)
    Arm Type
    Active Comparator
    Arm Description
    patients received pregabalin 300 mg 2 hours preoperatively.
    Arm Title
    Group III (pregabaline 300 twice)
    Arm Type
    Active Comparator
    Arm Description
    patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose.
    Arm Title
    Group IV (pregabaline 600)
    Arm Type
    Active Comparator
    Arm Description
    patients received pregabalin 600 mg 2 hours preoperatively
    Intervention Type
    Drug
    Intervention Name(s)
    pregabaline 300 mg once.
    Intervention Description
    patients received pregabaline 300 mg 2 hours pre-operatively.
    Intervention Type
    Drug
    Intervention Name(s)
    pregabaline 300 mg twice.
    Intervention Description
    patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later.
    Intervention Type
    Drug
    Intervention Name(s)
    pregabaline 600 mg once.
    Intervention Description
    patients received pregabaline 600 mg 2 hours pre-operatively.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    patients received placebo
    Primary Outcome Measure Information:
    Title
    visual analogue scale (VAS) score
    Description
    analgesic efficacy of study drugs as represented by the VAS score of the patients in the first 24 hours.
    Time Frame
    24 hours postoperatively
    Title
    postoperative opioid consumption
    Description
    ability of study drugs to reduce the postoperative opioid analgesic consumption.
    Time Frame
    24 hours postoperatively
    Title
    time to first request of opioid analgesia
    Description
    ability of the study drugs to delay the request of rescue opioid analgesia.
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Safety assessed by incidence of side effects
    Description
    represented by the incidence of side effects during the follow up period of 24 hours.
    Time Frame
    24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

    We'll reach out to this number within 24 hrs