NCT04814745

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

January 15, 2021

Last Update Submit

November 7, 2021

Conditions

Catheter Related Complication

Outcome Measures

Primary Outcomes (1)

  • catheter related bladder discomfort syndrome

    grade 0 to III

    immediately after surgery

Secondary Outcomes (1)

  • pain relief

    immediately after surgery

Study Arms (3)

morphine

ACTIVE COMPARATOR

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

Drug: intrathecal infusion

tramadol

ACTIVE COMPARATOR

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

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

Drug: Ropivacaine injection

Interventions

intrathecal infusionDRUG

morphine 150 mcg will be used by intrathecal administration

Also known as: morphine
morphine
Intravenous InfusionDRUG

tramadol administration

Also known as: tramadol
tramadol
Ropivacaine injectionDRUG

bilateral transversus abdominis plane block by using ropivacaine 80 mg

Also known as: transversus abdominis plane lock
ropivacaine

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients scheduled for robotic assisted laparoscopic prostatectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrea

Roma, Rome, 00166, Italy

Location

MeSH Terms

Interventions

MorphineInfusions, IntravenousTramadolRopivacaine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAdministration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, ParenteralCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsAnilidesAmidesAniline Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2021

First Posted

March 24, 2021

Study Start

July 7, 2020

Primary Completion

January 30, 2021

Study Completion

February 1, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

IT(1)