Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO) (TORNADO)

November 7, 2021 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Intrathecal Morphine Compared to Intravenous Tramadol and Transversus Abdominal Plane Block for Catheter Related Bladder Discomfort Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Roma, Rome, Italy, 00166
        • Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2020

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 7, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3236 (Ethical Committee authorization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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