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Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT04814745
Collaborator
(none)
33
Enrollment
1
Location
3
Arms
6.9
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: intrathecal infusion
  • Drug: Intravenous Infusion
  • Drug: Ropivacaine injection
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intrathecal Morphine Compared to Intravenous Tramadol and Transversus Abdominal Plane Block for Catheter Related Bladder Discomfort Syndrome
Actual Study Start Date :
Jul 7, 2020
Actual Primary Completion Date :
Jan 30, 2021
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. catheter related bladder discomfort syndrome [immediately after surgery]

      grade 0 to III

    Secondary Outcome Measures

    1. pain relief [immediately after surgery]

      assessment of post-operative pain by a 0 to 10 numeric rating score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andrea Roma Rome Italy 00166

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT04814745
    Other Study ID Numbers:
    • 3236
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Morphine
    Tramadol
    Ropivacaine

    Study Results

    No Results Posted as of Nov 15, 2021