Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
1
Chronic Tonsillitis
Prove the superiority of ropivacain against lidocain regarding postoperative pain after tonsillectomy.
Key facts
- Sponsor
- Tauernkliniken GmbH A.ö. Tauernklinikum - Standort Zell am See
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Trial duration
- 26 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Prove the superiority of ropivacain against lidocain regarding postoperative pain after tonsillectomy.
Conditions and MedDRA coding
Chronic Tonsillitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age: 18 years or older
- Chronic Tonsillitis
- Indication for tonsillectomy set by an otorhinolaryngologist
Exclusion criteria 10
- Intake of pain medication within 24h prior to the operation
- patients with peritonsillary absesses
- patients with known allergies on any used medication within the protocols
- patients who are unwilling or uncooperative
- patients who have a postoperative bleeding that has to be treated with a secondary operation
- patients with severe renal or hepatal dysfunction
- Patients under 18 years of age
- Patients who take medication, which is not allowed/interferes with the study outcome, or is contraindicated to take together with any study medication, and can not be paused for the trail duration
- current pregnancy
- chronic illnesses that make it impossible to take part in the trail because of contraindications to take the study medication
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint of the study is the average postoperative pain score, measured using the Visual Analog Scale (VAS, 0–10), within the first 72 hours after tonsillectomy. Assessments will be conducted four times daily, for a total of 12 measurements.
Secondary endpoints 4
- Average postoperative pain score measured using the Visual Analog Scale (VAS, 0–10) after discharge, assessed four times daily for a total of 11 days (Day 4–14)
- Average amount of analgesics taken during the inpatient stay (Day 1–4), differentiated by two types of analgesic medications
- Average amount of analgesics taken during the inpatient stay (Day 1–4), differentiated by two types of analgesic medications
- Time to first rescue medication in hours and minutes from the end of surgery to administration
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
L-Adrenalin "Fresenius" spritzfertig 2,0 mg - Ampullen
PRD767210 · Product
- Active substance
- Epinephrine
- Substance synonyms
- Adrenaline, ADRENALINUM
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- SUBMUCOSAL USE
- Max daily dose
- 0.05 mg milligram(s)
- Max total dose
- 0.05 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA24 — EPINEPHRINE
- Marketing authorisation
- 1-21272
- MA holder
- FRESENIUS KABI AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ropivacainhydrochlorid Sintetica 5 mg/ml Injektionslösung
PRD1962128 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBMUCOSAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 82055.00.00
- MA holder
- SINTETICA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xylanaest 0,5 % mit Epinephrin 1:200.000 - Durchstechflaschen
PRD404083 · Product
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBMUCOSAL USE
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB52 — LIDOCAINE, COMBINATIONS
- Marketing authorisation
- 17.909
- MA holder
- GEBRO PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 6
SUB09920MIG · Substance
- Active substance
- Piritramide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 225 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01674MIG · Substance
- Active substance
- Diclofenac Sodium
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 2100 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08810MIG · Substance
- Active substance
- Metamizole Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 g gram(s)
- Max total dose
- 20 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00737MIG · Substance
- Active substance
- Benzydamine Hydrochloride
- Pharmaceutical form
- OROMUCOSAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 40 ml millilitre(s)
- Max total dose
- 560 mm millimeter(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03191MIG · Substance
- Active substance
- Metamizole Sodium Monohydrate
- Pharmaceutical form
- DROPS, SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 120 Gtt drop(s)
- Max total dose
- 1320 Gtt drop(s)
- Max treatment duration
- 11 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09608MIG · Substance
- Active substance
- Pantoprazole
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 280 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tauernkliniken GmbH A.ö. Tauernklinikum - Standort Zell am See
- Sponsor organisation
- Tauernkliniken GmbH A.ö. Tauernklinikum - Standort Zell am See
- Address
- Paracelsusstraße 8, A-5700 Zell am See
- City
- Zell am See
- Postcode
- 5700
- Country
- Austria
Scientific contact point
- Organisation
- Tauernkliniken GmbH A.ö. Tauernklinikum - Standort Zell am See
- Contact name
- Ildiko Takacs
Public contact point
- Organisation
- Tauernkliniken GmbH A.ö. Tauernklinikum - Standort Zell am See
- Contact name
- Ildiko Takacs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Tauernkliniken GmbH
Hals-, Nasen- und Ohren-Heilkunde, Paracelsusstrasse 8, 5700, Zell Am See
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 |
|---|---|---|---|---|---|
| Austria | 2025-06-26 | 2025-06-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Case Report Form | 1.1 |
| Protocol (for publication) | D1_Protocol 2025-520820-44-00 | 2.4 |
| Protocol (for publication) | D4_Patient facing documents Schmerzerfassung nach Entlassung | 1.1 |
| Protocol (for publication) | D4_Patient facing documents Schmerzerfassung stationar | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Ausschreibung TE Studie | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-520820-44-00 | 1.4 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-28 | Austria | Acceptable 2025-06-17
|
2025-06-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-28 | Austria | Acceptable 2025-06-17
|
2026-02-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-25 | Austria | Acceptable 2025-06-17
|
2026-05-25 |