Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Catheter Related Complication

Intervention / Treatment
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* Drug: intrathecal infusion
* Drug: Intravenous Infusion
* Drug: Ropivacaine injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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