Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain Following Radical Cystectomy

Treatments: Drug: pregabaline 600 mg once.; Drug: pregabaline 300 mg once.; Drug: pregabaline 300 mg twice.; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02724293

266

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

Group I (placebo)

Placebo Comparator group

Description:

patients received placebo.

Treatment:

Drug: placebo

Group II (pregabaline 300 once)

Active Comparator group

Description:

patients received pregabalin 300 mg 2 hours preoperatively.

Treatment:

Drug: pregabaline 300 mg once.

Group III (pregabaline 300 twice)

Active Comparator group

Description:

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

Treatment:

Drug: pregabaline 300 mg twice.

Group IV (pregabaline 600)

Active Comparator group

Description:

patients received pregabalin 600 mg 2 hours preoperatively

Treatment:

Drug: pregabaline 600 mg once.