Analgesia Robotic Gynaecological Surgery | NCT07169604

Studies
Analgesia Robotic Gynaecological Surgery

NCT07169604

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Sep 12, 2025Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Pain Management

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 1, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Aug 19, 2025

First Submission Date that Met QC Criteria

Sep 9, 2025

First Posted Date

Sep 12, 2025Actual

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

Sep 9, 2025

Last Update Posted Date

Sep 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

RUSSO ANDREA, medical doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Name	Class
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

we will retrospectively investigate the effect of intratecal morphine administration on postoperative pain relief for patients scheduled for robotic hysterectomy

Detailed Description

Not provided

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

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain scores	we will registered the visual analogue scale number	admission at PACU admission, discharge from PACU, 24 hours after surgery (T2)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for robotic hysterectomy acceptation of written informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with gynaecological malignant or benign condition needed for hysterectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario Policlinico Gemelli		Roma	RM	00166	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42115438	Derived	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.

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases