Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
200
Countries
1
Sites
3
Inguinal hernia open surgery recovery
To assess the efficacy of combined RS and TAP blocks in open inguinal hernia surgery and to analyze whether using RS+TAP blocks is beneficial to using a TAP block only
Key facts
- Sponsor
- Pirkanmaan hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 5 Feb 2025 → ongoing
- Decision date (initial)
- 2024-11-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the efficacy of combined RS and TAP blocks in open inguinal hernia surgery and to analyze whether using RS+TAP blocks is beneficial to using a TAP block only
Secondary objectives 1
- Secondary outcome is the assessment of efficacy of the TAP and RS blocks individually
Conditions and MedDRA coding
Inguinal hernia open surgery recovery
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Able to give a written informed consent, Aged 18 years or older at screening, Diagnosed with Inguinal hernia scheduled for open inguinal hernia surgery, Adequate Finnish language literacy, Unilateral surgery
Exclusion criteria 1
- Surgery that is planned to be performed under general or spinal anesthesia, Allergy or hypersensitivity to study medications or their ingredients, Pregnancy or breast-feeding, aim of becoming pregnant during the study, Inability to provide written informed consent, Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study, A history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements, Prior or concurrent malignancy, Surgery that was not planned as day surgery, Bilateral surgery, Additional surgery to inguinal hernioplasty, Age under 18 years, Inability to give informed consent, Patient refusal, Chronic pain or prior opioid medication, Psychiatric disorder as defined by: medication used
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Equivalent morphine consumption in the perioperative period and after surgery, divided in: Intraoperative period, the immediate postoperative period, defined as the time between discharge from the operating room and discharge from the hospital and seven postoperative days
Secondary endpoints 1
- postoperative pain, as defined by numerical rating scale (NRS), patient opinion of the efficacy of the pain treatment, postoperative nausea and vomiting (PONV), as defined as use of postoperative nausea medications, use of rescue analgesia, rescue hospitalization, intra- and postoperative durations, intraoperative anesthetic methods, analysis of patient flow and, anesthesiologic and surgical complications, depression and anxiety as measured by BDI and STAI queries
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ropivacaine hydrochloride Kabi 7,5 mg/ml injekcinis tirpalas
PRD10136845 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 112.5 mg milligram(s)
- Max total dose
- 112.5 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- LT/1/22/5005/002
- MA holder
- FRESENIUS KABI POLSKA SP. Z O.O.
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Natriumchloride 0,9% Fresenius Kabi oplossing voor infusie
PRD2128265 · 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 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- BE197127
- MA holder
- FRESENIUS KABI NV/SA
- MA country
- Belgium
- 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
- Aki Lumme
Public contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Saara Ojala
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 200 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Tampere University Hospital
Anestesia ja tehohoito, Elamanaukio 2, 33520, Tampere
Pirkanmaan hyvinvointialue
Anestesiologia ja tehohoito, Hatanpaankatu 24, 33900, Tampere
Pirkanmaan hyvinvointialue
Anestesiologia ja tehohoito, Salonkatu 24, 37600, Valkeakoski
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2025-02-05 | 2025-09-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_In response to RFI-CT-2024-513406-59-00-IN-006-01_tc | 3.0 |
| Protocol (for publication) | D1_Prototocol_2024-513406-59-00 | 3.0 |
| Protocol (for publication) | D4_BDI questionnaire | 1 |
| Protocol (for publication) | D4_Patient diary | 1 |
| Protocol (for publication) | D4_Seurantalomake hoitajille | 1 |
| Protocol (for publication) | D4_Short pain questionnaire | 1 |
| Protocol (for publication) | D4_STAI Questionnaire | 1 |
| Protocol (for publication) | D4_Tyytyvaisyyskysely potilaille | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment and informed consent process | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Ropivacain | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2024-513403-59-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-06 | Finland | Acceptable 2024-11-01
|
2024-11-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-06 | Finland | Acceptable 2024-11-01
|
2024-11-06 |