Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Catheter Related Complication

Treatments: Drug: Intravenous Infusion; Drug: intrathecal infusion; Drug: Ropivacaine injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04814745

3236

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 3 patient groups

morphine

Active Comparator group

Description:

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

Treatment:

Drug: intrathecal infusion

tramadol

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Infusion

ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine injection