Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

Study Overview
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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.

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

Conditions
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Postoperative Pain Following Radical Cystectomy

Intervention / Treatment
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* Drug: pregabaline 300 mg once.
* Drug: pregabaline 300 mg twice.
* Drug: pregabaline 600 mg once.
* Drug: placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale (VAS) score | 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 | ability of study drugs to reduce the postoperative opioid analgesic consumption. | 24 hours postoperatively | 
| time to first request of opioid analgesia | 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 | represented by the incidence of side effects during the follow up period of 24 hours. | 24 hours postoperatively |