Single-center, double-blind, placebo-controlled study evaluating the efficacy of pre-incisional local analgesia with ropivacaine and dexamethasone for pain management after tonsillectomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000202-29-PT

Enrollment

104

Registered

2019-02-01

Start date

2020-07-27

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Patients selected for tonsillectomy MedDRA version: 21.1 Level: PT Classification code 10044006 Term: Tonsillectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 7.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - American Society of Anesthesiologists (ASA) physical status I-II; - Surgical proposal of tonsillectomy; - Tonsillectomy performed by the cold shedding technique; - History of recurrent tonsillitis, caseous tonsillitis and / or peritonsillar abscess; 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 104 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Use of chronic analgesic medication; - ASA III-IV; - Coagulation disorders; - Intolerance or allergy to any of the drugs used in the study; - Suspected neoplastic disease; - Fever or acute respiratory tract infection in the last 3 weeks;

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of the association of local infiltration of ropivacaine and dexamethasone alone or in combination with the reduction of pain and the need for supplemental analgesia after tonsillectomy in the immediate and late postoperative period in individuals aged 18-65 years. ;Secondary Objective: To evaluate the recovery in the postoperative period as well as the possible occurrence of complications associated with the use of the pre-incisional infiltration technique in tonsillectomy.;Primary end point(s): - Alteration in Visual Analogue Scale values applied at rest and during swallowing; ;Timepoint(s) of evaluation of this end point: clinical visit	—

Measure

Time frame

Main Objective: To compare the effect of the association of local infiltration of ropivacaine and dexamethasone alone or in combination with the reduction of pain and the need for supplemental analgesia after tonsillectomy in the immediate and late postoperative period in individuals aged 18-65 years. ;Secondary Objective: To evaluate the recovery in the postoperative period as well as the possible occurrence of complications associated with the use of the pre-incisional infiltration technique in tonsillectomy.;Primary end point(s): - Alteration in Visual Analogue Scale values applied at rest and during swallowing; ;Timepoint(s) of evaluation of this end point: clinical visit

—

Secondary

Measure	Time frame
Secondary end point(s): - Time to first administration of analgesia; - Time to onset of water intake and liquid and solid oral diet;Timepoint(s) of evaluation of this end point: clinical visit	—

Countries

Portugal

Contacts

Public ContactMónica Gonçalves

Centro Clínico Académico - Braga, Associação (2CA-Braga)

351253027249

Outcome results

None listed

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