Preemptive Analgesia With Morphine Sulphate in Major Urological Surgery

NCT ID: NCT02041988

Last Updated: 2014-01-22

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

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce opioids administration during major urological surgery

Detailed Description

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The administration of oral morphine sulfate could be useful to reduce the use of opioids in major urological surgery. This study aims to assess the safety and efficacy of two different oral morphine sulphate doses 0,2 mg/kg vs 0,4mg/kg in major urological surgery.

Conditions

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Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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0,2 mg/kg oral morphine

Patients have been assigned to two groups of 20 individuals, they have been premedicated with oral morphine sulfate, 0,2 mg/kg group A, 0,4mg/kg group B.During surgery analgesic administration will be monitored

No interventions assigned to this group

0,4 mg/ kg oral morphine

morphine and analgesic consumption throughout surgery will be monitored

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

American Society of Anaesthesiologists physical status classification I/ II, age between 18 - 75, BMI 18 -30

Exclusion Criteria

American Society of Anaesthesiologists physical status classification III/ IV, renal and hepatic insufficiency, postoperative nausea and vomiting after oral opioids administrations, neurological and psychiatric disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Cannata

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco MD Cannata, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Umberto I

Locations

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Francesco Cannata

Rome, Rome, Italy

Site Status RECRUITING

Policlinico Umberto I

Rome, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco FC Cannata, MD

Role: CONTACT

+390649970283

Facility Contacts

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Francesco FC Cannata, MD

Role: primary

+390649970283

Francesco FC Cannata, MD

Role: primary

+390649970283

Other Identifiers

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1846/08.04.10

Identifier Type: -

Identifier Source: org_study_id

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