- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00480142
Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Oscar Liphshitz, MD
- Phone Number: 0524782736
- Email: liphshitz@clalit.org.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kmc070012CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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