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

Tracking Information

First Received Date ^ICMJE

April 26, 2007

Last Updated Date

June 5, 2007

Start Date ^ICMJE

July 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00480142 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy : Prospective Double Blind, Randomized, Placebo-Controlled Study

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Elective Laproscopic Bilateral Inguinal Hernia
Elective Laproscopic Cholecystectomy

Intervention ^ICMJE

Drug: Oxycodone 10 mg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

July 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Oscar Liphshitz, MD

0524782736

liphshitz@clalit.org.il

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00480142

Responsible Party

Study ID Numbers ^ICMJE

kmc070012CTIL

Study Sponsor ^ICMJE

Kaplan Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	patricia grosman, MD	Israel: Kaplan Hospital, Clalit Health Service
Study Chair:	Eli Mavor, MD	Israel:Clalit Health Service
Study Director:	oscar liphshitz, MD	Isreal: Kaplan: Clalit Health Service
Study Director:	Bella Almog, R.N MA	Israel: Kaplan: Clalit Health Service

Information Provided By

Kaplan Medical Center

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP