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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04814745
Other study ID # 3236
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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