Clinical trial • Phase IV • Oncology

Ropivacaine hydrochloride for Renal cancer

Phase IV trial of Ropivacaine hydrochloride for Renal cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Renal cancer
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-12-2024
First CTIS Authorization Date
21-01-2025

Trial design

Natriumchloride Fresenius Kabi 100 mg/ml (10%), concentrate for solution for infusion (placebo); route: injection; max total amount reported 30 ml.-controlled Phase IV trial across 1 site in Finland.

Comparator
Natriumchloride Fresenius Kabi 100 mg/ml (10%), concentrate for solution for infusion (placebo); route: injection; max total amount reported 30 ml.
Target Sample Size
90

Eligibility

Recruits 90 No vulnerable populations selected (isVulnerablePopulationSelected: false). Subject information and informed consent form available (document title: 'Tiedote ja suostumus_clean'). Minors are explicitly excluded ("Alle 18 vuoden ikä"), so assent procedures for minors are not applicable. Specific consent language, age-specific documents or languages available are not specified in the record..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Subject information and informed consent form available (document title: 'Tiedote ja suostumus_clean'). Minors are explicitly excluded ("Alle 18 vuoden ikä"), so assent procedures for minors are not applicable. Specific consent language, age-specific documents or languages available are not specified in the record.

Inclusion criteria

  • {"criterion_text":"- Munuaissyöpäpotilaat, joille suoritetaan laparoskooppinen radikaali nefrektomia"}

Exclusion criteria

  • {"criterion_text":"- Alle 18 vuoden ikä"}
  • {"criterion_text":"- Oksikodonin ja parasetamolin metaboliaan vaikuttavien lääkkeiden säännöllinen käyttö (mysiini-antibiootit, makrolidit, masennuslääkkeet, antiepileptit ja probenisidi)"}
  • {"criterion_text":"- Komplisoitunut tyypin 1 diabetes"}
  • {"criterion_text":"- Puutteellinen suomen kielen taito"}
  • {"criterion_text":"- Ko-operaation puute"}
  • {"criterion_text":"- Pitkittynyt kiputila muun syyn takia"}
  • {"criterion_text":"- Ei sovellu laparoskooppiseen leikkaukseen"}
  • {"criterion_text":"- Hankala maksan vajaatoiminta tai Parasetamoli ei sovi musta syystä"}
  • {"criterion_text":"- Kortisonilääkitys kotilääkityksissä"}
  • {"criterion_text":"- Ei pysty käyttämään oksikodonia"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- kumulatiivinen opiaatin kulutus 1, 2, 4, 8, 12, 16 ja 24 tuntia puudutuksen jälkeen","definition_or_measurement_approach":"Cumulative opioid consumption measured at 1, 2, 4, 8, 12, 16 and 24 hours after the block (as stated)."}

Secondary endpoints

  • {"endpoint_text":"- Aika puudutuksen laitosta ensimmäisen kipulääkkeen tarpeeseen","definition_or_measurement_approach":"Time from block placement to requirement for first analgesic (as stated)."}
  • {"endpoint_text":"- kipu levossa/liikkeellä","definition_or_measurement_approach":"Pain at rest and on movement (measurement method/scale not specified in the available record)."}

Recruitment

Planned Sample Size
90
Recruitment Window Months
108
Consent Approach
An informed consent form is available (document title: 'Tiedote ja suostumus_clean'). Participants provide informed consent; minors are excluded ("Alle 18 vuoden ikä"), so assent for minors is not applicable. Specific languages and detailed consent procedures are not specified in the available record.

Geography

Total Number Of Sites
1
Total Number Of Participants
90

Finland

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
21-01-2025
Processing Time Days
8
Number Of Sites
1
Number Of Participants
90

Sites

Site Name
Tampere University Hospital
Department Name
Intensive care unit
Principal Investigator Name
Maija-Liisa Kalliomäki
Principal Investigator Email
maija-liisa.kalliomaki@pirha.fi
Contact Person Name
Maija-Liisa Kalliomäki

Sponsor

Primary sponsor

Full Name
Pirkanmaan hyvinvointialue
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Ropivacain Fresenius Kabi 7,5 mg/ml injektioneste, liuos
Active Substance
Ropivacaine hydrochloride
Modality
Small molecule
Routes Of Administration
Injection
Route
Injection
Authorisation Status
Authorised
Maximum Dose
675 mg
Investigational Product Name
Dexamethasone Kabi 4 mg/ml solution for injection/infusion
Active Substance
Dexamethasone sodium phosphate
Modality
Small molecule
Routes Of Administration
Injection
Route
Injection
Authorisation Status
Authorised
Maximum Dose
100 mg
Investigational Product Name
Natriumchloride Fresenius Kabi 100 mg/ml (10%), concentraat for solution for infusion
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
Injection
Route
Injection
Authorisation Status
Authorised
Maximum Dose
30 ml
Combination Treatment
Yes

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