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 because the information has not been verified recently.
Verified May 2007 by Kaplan Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Kaplan Medical Center
ClinicalTrials.gov Identifier:
NCT00480142
First received: April 26, 2007
Last updated: June 5, 2007
Last verified: May 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on August 28, 2014