Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

March 30, 2016 updated by: Ahmad Mohammad Abd El-Rahman, Assiut University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group I (placebo)
patients received placebo.
Drug: placebo
patients received placebo
Active Comparator: Group II (pregabaline 300 once)
patients received pregabalin 300 mg 2 hours preoperatively.
Drug: pregabaline 300 mg once.
patients received pregabaline 300 mg 2 hours pre-operatively.
Active Comparator: Group III (pregabaline 300 twice)
patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose.
Drug: pregabaline 300 mg twice.
patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later.
Active Comparator: Group IV (pregabaline 600)
patients received pregabalin 600 mg 2 hours preoperatively
Drug: pregabaline 600 mg once.
patients received pregabaline 600 mg 2 hours pre-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours postoperatively
postoperative opioid consumption
Time Frame: 24 hours postoperatively
ability of study drugs to reduce the postoperative opioid analgesic consumption.
24 hours postoperatively
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.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 266

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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