Local anaesthesia for prevention of pain after removal of tonsils in adult patients

Topical anaesthesia for postoperative pain in adult patients undergoing tonsillectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003119-50-FI

Enrollment

160

Registered

2011-07-07

Start date

2011-08-17

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients undergoing tonsillectomy MedDRA version: 14.0 Level: PT Classification code 10044006 Term: Tonsillectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Naropin Product Name: Naropin Pharmaceutical Form: Injection CAS Number: 98717-15-8 Other descriptive name: ROPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Elective tonsillectomy as outpatient Operation under general anaesthesia ASA class I and II age over 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Tonsillar abscess under 2 weeks before operation, suspicion of malignant disease, disorder of coagulation, chronic pain medication, depression medication, allergy or contraindication for study drugs, body weigth 120 kg, inability to communicate in Finnish or Swedish language, inability to use the NRS pain scale

Design outcomes

Primary

Measure	Time frame
Main Objective: To improve pain relief after tonsillectomy;Secondary Objective: No;Primary end point(s): Pain intensity when swallowing measured on numeric rating scale (NRS) 0-10 (0 no pain, 10 worst possible pain) during 14 postoperative days. AUC (area under curve) of the pain intensity will be calculated.;Timepoint(s) of evaluation of this end point: First 14 postoperative days.	—

Secondary

Measure	Time frame
Secondary end point(s): Worst pain during two hours followup in PACU, and the amount of pain medication during 14 postoperative days.;Timepoint(s) of evaluation of this end point: Two hours (PACU) and 14 postoperative days (home).	—

Countries

Finland

Contacts

Public ContactHelsinki Univ. Central Hospital

Vesa Kontinen

vesa.kontinen@hus.fi358094711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026