Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04814745

Acronym

TORNADO

Enrollment

Registered

2021-03-24

Start date

2020-07-07

Completion date

2021-02-01

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Related Complication

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.

Interventions

DRUGintrathecal infusion

morphine 150 mcg will be used by intrathecal administration

DRUGIntravenous Infusion

tramadol administration

DRUGRopivacaine injection

bilateral transversus abdominis plane block by using ropivacaine 80 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026