Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy

Phase 4

• Conditions: Elective Laproscopic Bilateral Inguinal Hernia; Elective Laproscopic Cholecystectomy

• Registration Number: NCT00480142
• Lead Sponsor: Kaplan Medical Center

Brief Summary

A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).

CRO is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.Its safety and efficacy in the first 12-24 hours post operative has not been established.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-26
• Status Verified: 2007-05
• Study First Submitted QC: 2007-05-29
• Study First Posted: 2007-05-30
• Last Update Submitted: 2007-06-05
• Last Update Posted: 2007-06-06
• Study Start: 2007-07
• Study Completion: 2008-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Local ethic committee approval
• Written informed consent
• ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH

Exclusion Criteria

• Difficulty in communication
• Allergy to oxycodone and/or morphine
• Allergy to local anesthetic
• History of alcohol and substance abuse
• Treated depression
• Chronic use of opioid or tramadol or NSAIDS
• Pregnancy
• Obstructive sleep apnea
• Anticipated fiber optic intubation
• Severe hepatic or renal impairment
• Weight <50 kg or > 100 kg
• Conversion to laparotomy
• Patient extubated in PACU.
• Any prior abdominal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL