Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

NCT04814745 — Not applicable, Completed, 33 participants, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Registry	NCT04814745, acronym TORNADO
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: single, treatment
Enrollment	33 (Actual)
Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Conditions	Catheter Related Complication
Interventions	intrathecal infusion, Intravenous Infusion, Ropivacaine injection (Drug)
Dates	start 2020-07-07, primary completion 2021-01-30, completion 2021-02-01, first posted 2021-03-24, last updated 2021-11-15
Locations	1 site in Italy

-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

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+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.

+Arms and interventions

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

intrathecal infusion (Drug), also known as morphine: morphine 150 mcg will be used by intrathecal administration
Intravenous Infusion (Drug), also known as tramadol: tramadol administration
Ropivacaine injection (Drug), also known as transversus abdominis plane lock: bilateral transversus abdominis plane block by using ropivacaine 80 mg

+Outcome measures

Primary outcomes

catheter related bladder discomfort syndrome [immediately after surgery]: grade 0 to III

Secondary outcomes

pain relief [immediately after surgery]: assessment of post-operative pain by a 0 to 10 numeric rating score

+Eligibility

Sex: Male, ages: 18 Years to 90 Years

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

+Locations (1)

Facility	City	Country	Status
Andrea	Roma, Rome	Italy