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Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)

NCT ID: NCT04814745

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2021-02-01

Brief Summary

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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

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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.

Conditions

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Catheter Related Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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morphine

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

Group Type ACTIVE_COMPARATOR

intrathecal infusion

Intervention Type DRUG

morphine 150 mcg will be used by intrathecal administration

tramadol

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

Group Type ACTIVE_COMPARATOR

Intravenous Infusion

Intervention Type DRUG

tramadol administration

ropivacaine

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

Group Type ACTIVE_COMPARATOR

Ropivacaine injection

Intervention Type DRUG

bilateral transversus abdominis plane block by using ropivacaine 80 mg

Interventions

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intrathecal infusion

morphine 150 mcg will be used by intrathecal administration

Intervention Type DRUG

Intravenous Infusion

tramadol administration

Intervention Type DRUG

Ropivacaine injection

bilateral transversus abdominis plane block by using ropivacaine 80 mg

Intervention Type DRUG

Other Intervention Names

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morphine tramadol transversus abdominis plane lock

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Andrea

Roma, Rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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3236

Identifier Type: -

Identifier Source: org_study_id