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Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

NCT ID: NCT02724293

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-11-30

Brief Summary

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

Detailed Description

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Conditions

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Postoperative Pain Following Radical Cystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group I (placebo)

patients received placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

patients received placebo

Group II (pregabaline 300 once)

patients received pregabalin 300 mg 2 hours preoperatively.

Group Type ACTIVE_COMPARATOR

pregabaline 300 mg once.

Intervention Type DRUG

patients received pregabaline 300 mg 2 hours pre-operatively.

Group III (pregabaline 300 twice)

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

Group Type ACTIVE_COMPARATOR

pregabaline 300 mg twice.

Intervention Type DRUG

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

Group IV (pregabaline 600)

patients received pregabalin 600 mg 2 hours preoperatively

Group Type ACTIVE_COMPARATOR

pregabaline 600 mg once.

Intervention Type DRUG

patients received pregabaline 600 mg 2 hours pre-operatively.

Interventions

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pregabaline 300 mg once.

patients received pregabaline 300 mg 2 hours pre-operatively.

Intervention Type DRUG

pregabaline 300 mg twice.

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

Intervention Type DRUG

pregabaline 600 mg once.

patients received pregabaline 600 mg 2 hours pre-operatively.

Intervention Type DRUG

placebo

patients received placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Mohammad Abd El-Rahman

Lecturer of anesthesia, icu, and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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266

Identifier Type: -

Identifier Source: org_study_id