Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

Not Applicable

Completed

• Conditions: Catheter Related Complication
• Interventions: Drug: intrathecal infusion; Drug: Intravenous Infusion; Drug: Ropivacaine injection

• Registration Number: NCT04814745
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2020-07-07
• Study First Submitted: 2021-01-15
• Primary Completion: 2021-01-30
• Study Completion: 2021-02-01
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-07
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
catheter related bladder discomfort syndrome	immediately after surgery	grade 0 to III

Secondary Outcome Measures

Name	Time	Method
pain relief	immediately after surgery	assessment of post-operative pain by a 0 to 10 numeric rating score

Trial Locations

Locations (1)

Andrea; 🇮🇹 Roma, Rome, Italy