Preemptive Analgesia With Morphine Sulphate in Major Urological Surgery

Pain Clinical Trial

Official title:

Influence of Premedication With Oral Morphine Sulphate on Analgesic Consumption in Patient Undergoing Major Urological Surgery. Comparison Between Two Different Doses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02041988
• Other study ID #: 1846/08.04.10
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2013
• Last updated: January 17, 2014
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2014
• Source: University of Roma La Sapienza
• Contact: Francesco FC Cannata, MD
• Phone: +390649970283
• Email: francesco.cannata[@]uniroma1.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
Italy	Francesco Cannata	Rome
Italy	Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VAS score		six months	Yes
Other	side effects		six months	Yes
Primary	morphine sulphate consumption		six months	No
Secondary	vital signs		six months	No