Overview
Sponsor-declared trial summary
Renal cancer
Does Quadratus lumborum block diminish the need for rescue analgesia
Key facts
- Sponsor
- Pirkanmaan hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-01-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519910-30-00
- EudraCT number
- 2017-002254-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
Does Quadratus lumborum block diminish the need for rescue analgesia
Conditions and MedDRA coding
Renal cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Munuaissyöpäpotilaat, joille suoritetaan laparoskooppinen radikaali nefrektomia
Exclusion criteria 10
- Alle 18 vuoden ikä
- Komplisoitunut tyypin 1 diabetes
- Puutteellinen suomen kielen taito
- Ko-operaation puute
- Pitkittynyt kiputila muun syyn takia
- Ei sovellu laparoskooppiseen leikkaukseen
- Hankala maksan vajaatoiminta tai Parasetamoli ei sovi musta syystä
- Kortisonilääkitys kotilääkityksissä
- Ei pysty käyttämään oksikodonia
- Oksikodonin ja parasetamolin metaboliaan vaikuttavien lääkkeiden säännöllinen käyttö (mysiini-antibiootit, makrolidit, masennuslääkkeet, antiepileptit ja probenisidi)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- kumulatiivinen opiaatin kulutus 1, 2, 4, 8, 12, 16 ja 24 tuntia puudutuksen jälkeen
Secondary endpoints 2
- Aika puudutuksen laitosta ensimmäisen kipulääkkeen tarpeeseen
- kipu levossa/liikkeellä
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Ropivacain Fresenius Kabi 7,5 mg/ml injektioneste, liuos
PRD767207 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 675 mg milligram(s)
- Max total dose
- 675 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 27494
- MA holder
- FRESENIUS KABI AB
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Kabi 4 mg/ml solution for injection/infusion
PRD9554327 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 20220062
- MA holder
- FRESENIUS KABI BULGARIA EOOD
- MA country
- Bulgaria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumchloride Fresenius Kabi 100 mg/ml (10%), concentraat voor oplossing voor infusie
PRD2541503 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INJECTION
- Max daily dose
- 30 ml millilitre(s)
- Max total dose
- 30 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- RVG 103379
- MA holder
- FRESENIUS KABI NEDERLAND B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pirkanmaan hyvinvointialue
- Sponsor organisation
- Pirkanmaan hyvinvointialue
- Address
- Elamanaukio 2
- City
- Tampere
- Postcode
- 33520
- Country
- Finland
Scientific contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Maija-Liisa Kalliomäki
Public contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Maija-Liisa Kalliomäki
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 90 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma | NA |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Tiedote ja suostumus_clean | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | Dexametason_valmisteyhteenveto | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Ropivacain | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-11 | Finland | Acceptable 2025-01-21
|
2025-01-21 |