Intrathecal Morphine for Radical Robot Assisted Prostatec... | NCT04814745

Studies
Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

NCT04814745

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Nov 15, 2021Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Catheter Related Complication

Interventions

intrathecal infusion
Intravenous Infusion
Ropivacaine injection

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

Nov 2021

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

Jul 7, 2020Actual

Primary Completion Date

Jan 30, 2021Actual

Completion Date

Feb 1, 2021Actual

First Submitted Date

Jan 15, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 24, 2021Actual

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

Nov 7, 2021

Last Update Posted Date

Nov 15, 2021Actual

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

investigators aim to compare the efficacy of intrathecal morphine, intravenous tramadol and transversus abdominis plane block in the treatment of catheter related bladder discomfort syndrome in patients scheduled for robotic assisted laparoscopic prostatectomy

Detailed Description

patients scheduled for robot assisted laparoscopic prostatectomy will be treated depending on the belonging group. In the morphine group patients will receive intrathecal morphine 0,15 mg; in the transversus abdominis plane block patients will receive ropivacaine 80 mg; in the tramadol group patients will receive intravenous continuous infusion of tramadol 400 mg for the first 24 hours postoperatively. All data will be collected in the post anesthesia room and in the ward until the first post operative day.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
morphine	Active Comparator	morphine 150 mcg will be administered intrathecally before surgery by using a 25 Gauge with acre spinal needle	Drug: intrathecal infusion
tramadol	Active Comparator	tramadol 400 mg will be administered by using an elastomeric pump for 24 hours after surgery	Drug: Intravenous Infusion
ropivacaine	Active Comparator	at the end of surgery transversus abdominis plane block will be performed bilaterally and ropivacaine 80 mg will be used	Drug: Ropivacaine injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intrathecal infusion	Drug	morphine 150 mcg will be used by intrathecal administration	morphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
catheter related bladder discomfort syndrome	grade 0 to III	immediately after surgery

Secondary Outcomes

Measure	Description	Time Frame
pain relief	assessment of post-operative pain by a 0 to 10 numeric rating score	immediately after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients scheduled for robotic assisted laparoscopic prostatectomy

Exclusion Criteria:

coagulation disorders and platelet dysfunction for spinal arm
obesity for transversus abdominis plane block arm
left ventricular ejection fraction < 30%, end-stage renal disease and neurological disorders for all groups

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Andrea		Roma	Rome	00166	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine
D007262	Infusions, Intravenous
D014147	Tramadol
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided