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OpenTrials
Completed

NCT Number: NCT04814745

Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

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

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Key information

Conditions

Catheter Related Complication

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Andrea

Roma, Rome, 00166, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrathecal infusion

Drug

morphine 150 mcg will be used by intrathecal administration

Other names: morphine

Intravenous Infusion

Drug

tramadol administration

Other names: tramadol

Ropivacaine injection

Drug

bilateral transversus abdominis plane block by using ropivacaine 80 mg

Other names: transversus abdominis plane lock

Primary outcomes

  1. catheter related bladder discomfort syndrome

    Time frame: immediately after surgery

    grade 0 to III

Secondary outcomes

  1. pain relief

    Time frame: immediately after surgery

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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: TORNADO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2021
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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