Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

Phase 2

Completed

• Conditions: Postoperative Pain Following Radical Cystectomy
• Interventions: Drug: pregabaline 600 mg once.; Drug: placebo; Drug: pregabaline 300 mg once.; Drug: pregabaline 300 mg twice.

• Registration Number: NCT02724293
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2016-03
• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-03-30
• Last Update Submitted: 2016-03-30
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group IV (pregabaline 600)	pregabaline 600 mg once.	patients received pregabalin 600 mg 2 hours preoperatively
Group I (placebo)	placebo	patients received placebo.
Group II (pregabaline 300 once)	pregabaline 300 mg once.	patients received pregabalin 300 mg 2 hours preoperatively.
Group III (pregabaline 300 twice)	pregabaline 300 mg twice.	patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose.

Primary Outcome Measures

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

Secondary Outcome Measures

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