Clinical trial • Not applicable • Other

Ropivacaine hydrochloride for Chronic tonsillitis

Not applicable trial of Ropivacaine hydrochloride for Chronic tonsillitis.

Overview

Trial Therapeutic Area: Other
Trial Disease: Chronic tonsillitis
Trial Stage: Not applicable
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 28-03-2025
First CTIS Authorization Date: 22-06-2025

Trial design

Ropivacainhydrochlorid Sintetica 5 mg/ml Injektionslösung (Ropivacaine hydrochloride) — product record lists max total dose 50 mg; route: submucosal use. Xylanaest 0,5 % mit Epinephrin 1:200.000 - Durchstechflaschen (Lidocaine hydrochloride + Epinephrine) — product record lists max total dose 10 ml; route: submucosal use. L-Adrenalin "Fresenius" spritzfertig 2,0 mg - Ampullen (Epinephrine) listed as test product (max total dose 0.05 mg; route: submucosal use). No randomisation method or dosing schedule/timing for arms specified in the provided data.-controlled Not applicable trial across 1 site in Austria.

Comparator: Ropivacainhydrochlorid Sintetica 5 mg/ml Injektionslösung (Ropivacaine hydrochloride) — product record lists max total dose 50 mg; route: submucosal use. Xylanaest 0,5 % mit Epinephrin 1:200.000 - Durchstechflaschen (Lidocaine hydrochloride + Epinephrine) — product record lists max total dose 10 ml; route: submucosal use. L-Adrenalin "Fresenius" spritzfertig 2,0 mg - Ampullen (Epinephrine) listed as test product (max total dose 0.05 mg; route: submucosal use). No randomisation method or dosing schedule/timing for arms specified in the provided data.
Target Sample Size: 60
Trial Duration For Participant: 14

Eligibility

Recruits 60 Vulnerable population selected in registry metadata. Participants must be 18 years or older. Informed consent is addressed via a subject information and informed consent form document ("L1_SIS and ICF"). No further details on assent or specific vulnerable-population consent procedures are provided in the supplied files..

Pregnancy Exclusion: current pregnancy
Vulnerable Population: Vulnerable population selected in registry metadata. Participants must be 18 years or older. Informed consent is addressed via a subject information and informed consent form document ("L1_SIS and ICF"). No further details on assent or specific vulnerable-population consent procedures are provided in the supplied files.

Inclusion criteria

{"criterion_text":"- Age: 18 years or older\n- Chronic Tonsillitis\n- Indication for tonsillectomy set by an otorhinolaryngologist"}

Exclusion criteria

{"criterion_text":"- Intake of pain medication within 24h prior to the operation\n- chronic illnesses that make it impossible to take part in the trail because of contraindications to take the study medication\n- patients with peritonsillary absesses\n- patients with known allergies on any used medication within the protocols\n- patients who are unwilling or uncooperative\n- patients who have a postoperative bleeding that has to be treated with a secondary operation\n- patients with severe renal or hepatal dysfunction\n- Patients under 18 years of age\n- 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\n- current pregnancy"}

Endpoints

Primary endpoints

{"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured using the Visual Analog Scale (VAS, 0–10) within the first 72 hours after tonsillectomy; assessments conducted four times daily (total 12 measurements)."}

Secondary endpoints

{"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured using VAS (0–10) after discharge, assessed four times daily for Days 4–14 (11 days total)."}
{"endpoint_text":"- Average amount of analgesics taken during the inpatient stay (Day 1–4), differentiated by two types of analgesic medications","definition_or_measurement_approach":"Average amount of two types of analgesic medications taken during inpatient stay (Day 1–4); differentiated by medication type."}
{"endpoint_text":"- Average amount of analgesics taken during the inpatient stay (Day 1–4), differentiated by two types of analgesic medications","definition_or_measurement_approach":"Average amount of two types of analgesic medications taken during inpatient stay (Day 1–4); differentiated by medication type."}
{"endpoint_text":"- Time to first rescue medication in hours and minutes from the end of surgery to administration","definition_or_measurement_approach":"Measured as time interval (hours and minutes) from end of surgery to administration of first rescue medication."}

Recruitment

Planned Sample Size: 60
Recruitment Window Months: 7
Consent Approach: Informed consent obtained from participants (age 18 years or older) using a subject information and informed consent form (document 'L1_SIS and ICF'). No details on assent, age-specific consent documents, or available languages are provided in the supplied files.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 60

Austria

Earliest CTIS Part Ii Submission Date: 08-06-2025
Latest Decision Or Authorization Date: 28-02-2026
Processing Time Days: 265
Number Of Sites: 1
Number Of Participants: 60

Sites

Site Name: Tauernkliniken GmbH
Department Name: Hals-, Nasen- und Ohren-Heilkunde
Principal Investigator Name: Ildiko Takacs
Principal Investigator Email: ildiko.takacs@tauernklinikum.at
Contact Person Name: Ildiko Takacs
Contact Person Email: ildiko.takacs@tauernklinikum.at
Number Of Participants: 60

Sponsor

Primary sponsor

Full Name: Tauernkliniken GmbH A.ö. Tauernklinikum - Standort Zell am See
Organisation Type: Health care
Country Of Registered Address: Austria

Investigational products

Investigational Product Name: Ropivacainhydrochlorid Sintetica 5 mg/ml Injektionslösung
Active Substance: Ropivacaine hydrochloride
Modality: Small molecule
Routes Of Administration: Submucosal use
Route: Submucosal use
Authorisation Status: Authorised
Maximum Dose: 50 mg (max total dose)

Investigational Product Name: Xylanaest 0,5 % mit Epinephrin 1:200.000 - Durchstechflaschen
Active Substance: Lidocaine hydrochloride; Epinephrine
Modality: Small molecule
Routes Of Administration: Submucosal use
Route: Submucosal use
Authorisation Status: Authorised
Maximum Dose: 10 ml (max total dose)

Investigational Product Name: L-Adrenalin "Fresenius" spritzfertig 2,0 mg - Ampullen
Active Substance: Epinephrine
Modality: Small molecule
Routes Of Administration: Submucosal use
Route: Submucosal use
Authorisation Status: Authorised
Maximum Dose: 0.05 mg (max total dose)

Combination Treatment: Yes

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