Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

NCT02724293 | Completed Phase 2

• 1 other identifier: 266
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain Following Radical Cystectomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Safety assessed by incidence of side effects

  24 hours postoperatively

Study Arms (4)

Group I (placebo)

PLACEBO COMPARATOR

patients received placebo.

Drug: placebo

Group II (pregabaline 300 once)

ACTIVE COMPARATOR

patients received pregabalin 300 mg 2 hours preoperatively.

Drug: pregabaline 300 mg once.

Group III (pregabaline 300 twice)

ACTIVE COMPARATOR

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

Drug: pregabaline 300 mg twice.

Group IV (pregabaline 600)

ACTIVE COMPARATOR

patients received pregabalin 600 mg 2 hours preoperatively

Drug: pregabaline 600 mg once.

Interventions

pregabaline 300 mg once. DRUG

patients received pregabaline 300 mg 2 hours pre-operatively.

Group II (pregabaline 300 once)

pregabaline 300 mg twice. DRUG

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

Group III (pregabaline 300 twice)

pregabaline 600 mg once. DRUG

patients received pregabaline 600 mg 2 hours pre-operatively.

Group IV (pregabaline 600)

placebo DRUG

patients received placebo

Group I (placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, icu, and pain management

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: March 31, 2016
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03