Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

Catheter Related Complication Clinical Trial

— TORNADO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814745
• Other study ID #: 3236
• Status: Completed
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: November 2021
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 1, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Complication

Intervention

Drug:
• intrathecal infusion
morphine 150 mcg will be used by intrathecal administration
• Intravenous Infusion
tramadol administration
• Ropivacaine injection
bilateral transversus abdominis plane block by using ropivacaine 80 mg

Locations

Country	Name	City	State
Italy	Andrea	Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catheter related bladder discomfort syndrome	grade 0 to III	immediately after surgery
Secondary	pain relief	assessment of post-operative pain by a 0 to 10 numeric rating score	immediately after surgery