PainNCT02041988
Preemptive Analgesia With Morphine Sulphate in Major Urological Surgery
An observational study of Pain, run by University of Roma La Sapienza at 2 sites in Italy.
Trial summary
In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce opioids administration during major urological surgery Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- Feb 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients selected for major urological surgery
Who may be able to join
- American Society of Anaesthesiologists physical status classification I/ II, age between 18 - 75, BMI 18 -30
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Francesco Cannata
Rome, Rome, 00141
Francesco FC Cannata, MD, +390649970283, francesco.cannata@uniroma1.it
- Recruiting
Policlinico Umberto I
Rome, Rome, 00141
Francesco FC Cannata, MD, +390649970283, francesco.cannata@uniroma1.it
Francesco FC Cannata, MD
About this study
Official title: Influence of Premedication With Oral Morphine Sulphate on Analgesic Consumption in Patient Undergoing Major Urological Surgery. Comparison Between Two Different Doses
In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce opioids administration during major urological surgery
Read the 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.
- Conditions
- Pain
- Keywords
- premedication, oral morphine, preemptive analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine sulphate consumption
Measured: six months
Secondary outcomes (1)
vital signs
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Cannata, University of Roma La Sapienza
- Investigators
- Francesco MD Cannata, MD, Principal investigator, Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041988
- Sponsor's protocol ID
- 1846/08.04.10
- Status last verified
- Jan 2014
- First submitted
- 1 Jul 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Premedication With Oral Morphine Sulphate on Analgesic Consumption in Patient Undergoing Major Urological Surgery. Comparison Between Two Different Doses
- ClinicalTrials.gov ID
- NCT02041988
- Acronym / sponsor ID
- 1846/08.04.10
- Conditions
- Pain
- Keywords
- premedication, oral morphine, preemptive analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected for major urological surgery
Key inclusion criteria (1 listed)
- American Society of Anaesthesiologists physical status classification I/ II, age between 18 - 75, BMI 18 -30
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
morphine sulphate consumption
Time frame: six months
1 secondary outcome
vital signs
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco MD Cannata, MD principal investigator
Policlinico Umberto I
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by University of Roma La Sapienza at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco FC Cannata, MD (+390649970283, francesco.cannata@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine sulphate consumption (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.