Post Operative AnalgesiaNCT02146638
Post Operative Pain Control: Morphine vs Fentanyl
A study testing Morphine and Fentanyl in people with Post Operative Analgesia, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Aim of this study is to compare benefits and disadvantages in using continuous infusion of morphine or fentanyl for post operative analgesia. Read more about this study
- Who is it for?
- Ages 35 to 59 years, women only
- Conditions the study is for
- Post Operative Analgesia
- What is being tested?
- Morphine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Sep 2012
- Phase
- Interventional
- 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 35 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA 1 or 2 patients
- undergoing major gynaecological surgery
Who cannot join
- age > 60 years
- obesity (BMI>30 Kg/m2)
- cardiac and respiratory diseases
- renal impairment
- liver disorders
- allergies to any drug used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Operative Pain Control: Continuous Infusion of Morphine vs Fentanyl. Clinical Outcomes
Aim of this study is to compare benefits and disadvantages in using continuous infusion of morphine or fentanyl for post operative analgesia.
- Conditions
- Post Operative Analgesia
- Keywords
- post operative analgesia, morphine, fentanyl
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 |
|---|---|---|
| Morphine | Active comparator | Patients received morphine 0.02 mg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline. Receives: Drug: Morphine |
| Fentanyl | Experimental | Patients received Fentanyl 0.3 mcg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
data were recorded at 1,6,18 and 24 hours after surgery
Measured: data were recorded during the 24 post operative hours
Secondary outcomes (1)
analgesic requirements
if VAS value was equal or higher than 6 patients received ketorolac 30 mg iv
Measured: during the 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Bevilacqua, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146638
- Sponsor's protocol ID
- MFN-6932-AS
- Status last verified
- May 2014
- First submitted
- 10 Jan 2013
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Pain Control: Continuous Infusion of Morphine vs Fentanyl. Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02146638
- Acronym / sponsor ID
- MFN-6932-AS
- Conditions
- Post Operative Analgesia
- Keywords
- post operative analgesia, morphine, fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 May 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.
Aim of this study is to compare benefits and disadvantages in using continuous infusion of morphine or fentanyl for post operative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: MorphinePatients received morphine 0.02 mg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline. |
| Fentanyl | Experimental | Drug: FentanylPatients received Fentanyl 0.3 mcg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline. |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA 1 or 2 patients
- undergoing major gynaecological surgery
Key exclusion criteria (6 listed)
- age > 60 years
- obesity (BMI>30 Kg/m2)
- cardiac and respiratory diseases
- renal impairment
- liver disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine | Drug | Morphine |
| FentanylAlso: Fentanest | Drug | Fentanyl |
Primary outcome
pain scores
Time frame: data were recorded during the 24 post operative hours
data were recorded at 1,6,18 and 24 hours after surgery
1 secondary outcome
analgesic requirements
Time frame: during the 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine and Fentanyl in people with Post Operative Analgesia, run by Catholic University of the Sacred Heart at 1 site 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scores (time frame: data were recorded during the 24 post operative hours). 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 26 May 2014.