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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Elective Laproscopic Bilateral Inguinal Hernia Elective Laproscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oxycodone 10 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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patricia grosman, MD

Role: PRINCIPAL_INVESTIGATOR

Israel: Kaplan Hospital, Clalit Health Service

Eli Mavor, MD

Role: STUDY_CHAIR

Israel:Clalit Health Service

oscar liphshitz, MD

Role: STUDY_DIRECTOR

Isreal: Kaplan: Clalit Health Service

Bella Almog, R.N MA

Role: STUDY_DIRECTOR

Israel: Kaplan: Clalit Health Service

Central Contacts

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Oscar Liphshitz, MD

Role: CONTACT

[email protected]

0524782736

Other Identifiers

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kmc070012CTIL

Identifier Type: -

Identifier Source: org_study_id