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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

Primary Purpose

Elective Laproscopic Bilateral Inguinal Hernia, Elective Laproscopic Cholecystectomy

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Oxycodone 10 mg

About this trial

This is an interventional treatment trial for Elective Laproscopic Bilateral Inguinal Hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00480142

First Posted

April 26, 2007

Last Updated

June 5, 2007

Sponsor

Kaplan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00480142

Brief 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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Kaplan Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elective Laproscopic Bilateral Inguinal Hernia, Elective Laproscopic Cholecystectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Oxycodone 10 mg

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oscar Liphshitz, MD

Phone

0524782736

liphshitz@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

patricia grosman, MD

Organizational Affiliation

Israel: Kaplan Hospital, Clalit Health Service

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eli Mavor, MD

Organizational Affiliation

Israel:Clalit Health Service

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

oscar liphshitz, MD

Organizational Affiliation

Isreal: Kaplan: Clalit Health Service

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bella Almog, R.N MA

Organizational Affiliation

Israel: Kaplan: Clalit Health Service

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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