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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480142
First Posted: May 30, 2007
Last Update Posted: June 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaplan Medical Center
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


Further study details as provided by Kaplan Medical Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00480142     History of Changes
Other Study ID Numbers: kmc070012CTIL
First Submitted: April 26, 2007
First Posted: May 30, 2007
Last Update Posted: June 6, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents