Catheter Related ComplicationTORNADONCT04814745
Intrathecal Morphine for Radical Robot Assisted Prostatectomy (TORNADO)
A study testing intrathecal infusion, Intravenous Infusion and Ropivacaine injection in people with Catheter Related Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Catheter Related Complication
- What is being tested?
- intrathecal infusion, Intravenous Infusion and Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jul 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients scheduled for robotic assisted laparoscopic prostatectomy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Morphine Compared to Intravenous Tramadol and Transversus Abdominal Plane Block for Catheter Related Bladder Discomfort Syndrome
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
Read the 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.
- Conditions
- Catheter Related Complication
- Being tested
- intrathecal infusion, Intravenous Infusion, Ropivacaine injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal infusionDrug
Also called morphine
morphine 150 mcg will be used by intrathecal administration
Intravenous InfusionDrug
Also called tramadol
tramadol administration
Ropivacaine injectionDrug
Also called transversus abdominis plane lock
bilateral transversus abdominis plane block by using ropivacaine 80 mg
| Study group | Role | What they receive |
|---|---|---|
| morphine | Active comparator | morphine 150 mcg will be administered intrathecally before surgery by using a 25 Gauge with acre spinal needle Receives: Drug: intrathecal infusion |
| tramadol | Active comparator | tramadol 400 mg will be administered by using an elastomeric pump for 24 hours after surgery Receives: Drug: Intravenous Infusion |
| ropivacaine | Active comparator | at the end of surgery transversus abdominis plane block will be performed bilaterally and ropivacaine 80 mg will be used Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheter related bladder discomfort syndrome
grade 0 to III
Measured: immediately after surgery
Secondary outcomes (1)
pain relief
assessment of post-operative pain by a 0 to 10 numeric rating score
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start7 Jul 2020
- Primary completion30 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814745
- Sponsor's protocol ID
- 3236
- Acronym
- TORNADO
- Status last verified
- Nov 2021
- First submitted
- 15 Jan 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine Compared to Intravenous Tramadol and Transversus Abdominal Plane Block for Catheter Related Bladder Discomfort Syndrome
- ClinicalTrials.gov ID
- NCT04814745
- Acronym / sponsor ID
- TORNADO / 3236
- Conditions
- Catheter Related Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| morphine | Active comparator | Drug: intrathecal infusionmorphine 150 mcg will be administered intrathecally before surgery by using a 25 Gauge with acre spinal needle |
| tramadol | Active comparator | Drug: Intravenous Infusiontramadol 400 mg will be administered by using an elastomeric pump for 24 hours after surgery |
| ropivacaine | Active comparator | Drug: Ropivacaine injectionat the end of surgery transversus abdominis plane block will be performed bilaterally and ropivacaine 80 mg will be used |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients scheduled for robotic assisted laparoscopic prostatectomy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrathecal infusionAlso: morphinemorphine 150 mcg will be used by intrathecal administration | Drug | morphine |
| Intravenous InfusionAlso: tramadoltramadol administration | Drug | tramadol |
| Ropivacaine injectionAlso: transversus abdominis plane lockbilateral transversus abdominis plane block by using ropivacaine 80 mg | Drug | ropivacaine |
Primary outcome
catheter related bladder discomfort syndrome
Time frame: immediately after surgery
grade 0 to III
1 secondary outcome
pain relief
Time frame: immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrathecal infusion, Intravenous Infusion and Ropivacaine injection in people with Catheter Related Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catheter related bladder discomfort syndrome (time frame: immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.