Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

Postoperative Pain Following Radical Cystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724293
• Other study ID #: 266
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 25, 2016
• Last updated: March 30, 2016
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Following Radical Cystectomy

Intervention

Drug:
• pregabaline 300 mg once.
patients received pregabaline 300 mg 2 hours pre-operatively.
• pregabaline 300 mg twice.
patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later.
• pregabaline 600 mg once.
patients received pregabaline 600 mg 2 hours pre-operatively.
• placebo
patients received placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	postoperative opioid consumption	ability of study drugs to reduce the postoperative opioid analgesic consumption.	24 hours postoperatively	No
Primary	time to first request of opioid analgesia	ability of the study drugs to delay the request of rescue opioid analgesia.	24 hours postoperatively	No
Secondary	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	Yes