Pain ManagementNCT07169604
Analgesia Robotic Gynaecological Surgery
An observational study of Pain Management, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
we will retrospectively investigate the effect of intratecal morphine administration on postoperative pain relief for patients scheduled for robotic hysterectomy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain Management
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Dec 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with gynaecological malignant or benign condition needed for hysterectomy
Who may be able to join
- patients scheduled for robotic hysterectomy acceptation of written informed consent
Who cannot join
- were contraindications to neuraxial anesthesia (such as coagulopathies, platelet count below 100,000/mm³ or thrombocytopathy), severe valvular heart disease, left ventricular ejection fraction less than 35%, history of obstructive or restrictive pulmonary disease, or significant neurological disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Policlinico Gemelli
Roma, RM, 00166
About this study
Official title: PERIOPERATIVE EFFECTS OF SPINAL ANALGESIA REGIMEN FOR ROBOTIC HYSTERECTOMY: A RETROSPECTIVE ANALYSIS
we will retrospectively investigate the effect of intratecal morphine administration on postoperative pain relief for patients scheduled for robotic hysterectomy
- Conditions
- Pain Management
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
we will registered the visual analogue scale number
Measured: admission at PACU admission, discharge from PACU, 24 hours after surgery (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Jan 2021
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
- Responsible party
- Principal investigator, RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169604
- Sponsor's protocol ID
- 3307
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Russo A, Perelli F, Aceto P, Arcieri M, Bernardini F, Pregnolato S, Moroni R, Dogareschi T, Meroi F, Costantini B, Gallotta V, Fanfani F, Driul L, Fagotti A, Bove T, Restaino S, Antonelli M, Vizzielli G. Intrathecal morphine dose optimization in robotic-assisted laparoscopic hysterectomy: a dual-center cohort study. J Robot Surg. 2026 May 12;20(1):481. doi: 10.1007/s11701-026-03445-y.
PubMed 42115438
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERIOPERATIVE EFFECTS OF SPINAL ANALGESIA REGIMEN FOR ROBOTIC HYSTERECTOMY: A RETROSPECTIVE ANALYSIS
- ClinicalTrials.gov ID
- NCT07169604
- Acronym / sponsor ID
- 3307
- Conditions
- Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 Sep 2025 (actual)
- 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.
we will retrospectively investigate the effect of intratecal morphine administration on postoperative pain relief for patients scheduled for robotic hysterectomy
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with gynaecological malignant or benign condition needed for hysterectomy
Key inclusion criteria (1 listed)
- patients scheduled for robotic hysterectomy acceptation of written informed consent
Key exclusion criteria (1 listed)
- were contraindications to neuraxial anesthesia (such as coagulopathies, platelet count below 100,000/mm³ or thrombocytopathy), severe valvular heart disease, left ventricular ejection fraction less than 35%, history of obstructive or restrictive pulmonary disease, or significant neurological 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
pain scores
Time frame: admission at PACU admission, discharge from PACU, 24 hours after surgery (T2)
we will registered the visual analogue scale number
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 12 Sep 2025.
- Derived from this study: PubMed 42115438Russo A, Perelli F, Aceto P, Arcieri M, Bernardini F, Pregnolato S, Moroni R, Dogareschi T, Meroi F, Costantini B, Gallotta V, Fanfani F, Driul L, Fagotti A, Bove T, Restaino S, Antonelli M, Vizzielli G. Intrathecal morphine dose optimization in robotic-assisted laparoscopic hysterectomy: a dual-center cohort study. J Robot Surg. 2026 May 12;20(1):481. doi: 10.1007/s11701-026-03445-y.
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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?
An observational study of Pain Management, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 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: finished, as of the sponsor's last update on 12 Sep 2025. 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: admission at PACU admission, discharge from PACU, 24 hours after surgery (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169604, which also lists 1 linked publication.
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 12 Sep 2025.