Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02724293

Enrollment

Registered

2016-03-31

Start date

2014-09-30

Completion date

2015-11-30

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain Following Radical Cystectomy

Brief summary

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

Interventions

DRUGpregabaline 300 mg once.

patients received pregabaline 300 mg 2 hours pre-operatively.

DRUGpregabaline 300 mg twice.

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

DRUGpregabaline 600 mg once.

patients received pregabaline 600 mg 2 hours pre-operatively.

DRUGplacebo

patients received placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026