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

First Received: April 26, 2007 Last Updated: June 5, 2007 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Hernia

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

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

No publications provided

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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Oxycodone
Hernia, Abdominal
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Hernia, Inguinal
Analgesics, Opioid

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Oxycodone
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Sensory System Agents
Therapeutic Uses

Hernia
Hernia, Abdominal
Analgesics
Peripheral Nervous System Agents
Hernia, Inguinal
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 11, 2009