Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy
Information source: Kaplan Medical Center
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Elective Laproscopic Bilateral Inguinal Hernia; Elective Laproscopic Cholecystectomy
Intervention: Oxycodone 10 mg (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Kaplan Medical Center Official(s) and/or principal investigator(s):
patricia grosman, MD, Principal Investigator, Affiliation: Israel: Kaplan Hospital, Clalit Health Service
Eli Mavor, MD, Study Chair, Affiliation: Israel:Clalit Health Service
oscar liphshitz, MD, Study Director, Affiliation: Isreal: Kaplan: Clalit Health Service
Bella Almog, R.N MA, Study Director, Affiliation: Israel: Kaplan: Clalit Health Service
Overall contact:
Oscar Liphshitz, MD, Phone: 0524782736, Email: liphshitz@clalit.org.il
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Oscar Liphshitz, MD, Phone: 0524782736, Email: liphshitz@clalit.org.il Additional Information
Starting date: July 2007
Ending date: July 2008
Last updated: June 5, 2007
|
