Preemptive Analgesia With Morphine Sulphate in Major Urol... | NCT02041988

Studies
Preemptive Analgesia With Morphine Sulphate in Major Urological Surgery

NCT02041988

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Jan 22, 2014Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jul 2014Estimated

First Submitted Date

Jul 1, 2013

First Submission Date that Met QC Criteria

Jan 17, 2014

First Posted Date

Jan 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2014

Last Update Posted Date

Jan 22, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francesco Cannata, Medical Doctor, University of Roma La SapienzaPrincipal Investigator

Lead Sponsor

University of Roma La SapienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
0,4 mg/ kg oral morphine		morphine and analgesic consumption throughout surgery will be monitored

Interventions

Not provided

Measure	Description	Time Frame
morphine sulphate consumption		six months

Measure	Description	Time Frame
vital signs		six months

Measure	Description	Time Frame
VAS score		six months
side effects		six months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients selected for major urological surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco FC Cannata, MD	Contact	+390649970283		francesco.cannata@uniroma1.it

Overall Officials

Name	Affiliation	Role
Francesco MD Cannata, MD	Policlinico Umberto I	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Francesco Cannata	Recruiting	Rome	Rome	00141	Italy

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided