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Clinical Trials/NCT04814745
NCT04814745
Completed
N/A

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country33 target enrollmentJuly 7, 2020

Overview

Phase
N/A
Intervention
intrathecal infusion
Conditions
Catheter Related Complication
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
33
Locations
1
Primary Endpoint
catheter related bladder discomfort syndrome
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 7, 2020
End Date
February 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

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

Arms & Interventions

morphine

morphine 150 mcg will be administered intrathecally before surgery by using a 25 Gauge with acre spinal needle

Intervention: intrathecal infusion

tramadol

tramadol 400 mg will be administered by using an elastomeric pump for 24 hours after surgery

Intervention: Intravenous Infusion

ropivacaine

at the end of surgery transversus abdominis plane block will be performed bilaterally and ropivacaine 80 mg will be used

Intervention: Ropivacaine injection

Outcomes

Primary Outcomes

catheter related bladder discomfort syndrome

Time Frame: immediately after surgery

grade 0 to III

Secondary Outcomes

  • pain relief(immediately after surgery)

Study Sites (1)

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