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

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

This study is not yet open for participant recruitment.
Verified by Kaplan Medical Center, May 2007

Sponsored by:	Kaplan Medical Center
Information provided by:	Kaplan Medical Center
ClinicalTrials.gov Identifier:	NCT00480142

Purpose

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.

Condition	Intervention	Phase
Elective Laproscopic Bilateral Inguinal Hernia Elective Laproscopic Cholecystectomy	Drug: Oxycodone 10 mg	Phase IV

MedlinePlus related topics:

Hernia

Drug Information available for:

Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Kaplan Medical Center:

Estimated Enrollment:	100
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2008

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480142

Contacts


Contact: Oscar Liphshitz, MD	0524782736	liphshitz@clalit.org.il

Sponsors and Collaborators

Kaplan Medical Center

Investigators


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

More Information

Study ID Numbers:	kmc070012CTIL
First Received:	April 26, 2007
Last Updated:	June 5, 2007
ClinicalTrials.gov Identifier:	NCT00480142
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Hernia

Oxycodone

Hernia, Abdominal

Hernia, Inguinal

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Analgesics, Opioid

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008