CT Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine + Dexamethasone in Pain Management After Tonsillectomy

NCT ID: NCT05504967

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2023-07-01

Brief Summary

This study is a randomized, controlled, double-blind clinical trial to evaluate the effect of local infiltration of ropivacaine and dexamethasone, alone or in association, in the reduction of pain and the need for supplementary analgesia, after tonsillectomy, in the immediate and late postoperative period, in individuals aged 18 to 65 years.

The present clinical trial will include 4 study groups, each with different content of infiltration into the amygdaline locus. One group will have ropivacaine in the infiltration, the other will have dexamethasone and another the association of these two drugs. In order to better understand the effectiveness of these drugs, there will also be a control group, in which saline solution will be infiltrated.

Approximately 104 individuals, aged 18 to 65 years, proposed for tonsillectomy will be included in the study, i.e., 26 subjects in each study group.

Postoperative pain will be characterized by self-assessment through the Visual Analog Scale (VAS, 100mm) at various moments of the study, namely in the preoperative consultation, in the pre-anesthetic consultation, at hospital admission and in the postoperative period until the 15th day after the surgery.

The aim of this study is not to eliminate intra and postoperative analgesia, but rather account for the need for analgesia depending on the different infiltration content peramygdalin. For this, in the postoperative period, a careful pain monitoring, having first-line analgesic and rescue medication for use immediate response in the face of minimal pain assessed by validated pain scales. It is intended, therefore, to record which analgesic drugs and in what doses were necessary.

Conditions

Tonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dexamethasone

12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total).

Single dosage pre-incisional.

Group Type: ACTIVE_COMPARATOR

Oradexon

Intervention Type: DRUG

With a syringe aspirate 2.5 ml of a 5mg/ml dexamethasone solution, for a total of 12.5mg. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

Saline solution

Intervention Type: DRUG

With a syringe, aspirate 2.5 ml of a 0.9% NaCl solution. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

ropivacain

18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total).

Single dosage pre-incisional.

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

With a syringe aspirate 2.5 ml of a 7.5mg/ml dexamethasone solution, for a total of 18.75mg. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

Saline solution

Intervention Type: DRUG

With a syringe, aspirate 2.5 ml of a 0.9% NaCl solution. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

ropivacain + dexamethasone

18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca).

Single dosage pre-incisional.

Group Type: EXPERIMENTAL

Oradexon

Intervention Type: DRUG

With a syringe aspirate 2.5 ml of a 5mg/ml dexamethasone solution, for a total of 12.5mg. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

Ropivacaine

Intervention Type: DRUG

With a syringe aspirate 2.5 ml of a 7.5mg/ml dexamethasone solution, for a total of 18.75mg. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

placebo

Saline solution (NaCl 0.9%) peramygdalin infiltration (in each loca). Single dosage pre-incisional. 4 syringes must be prepared, two for each of the tonsil sites.

Group Type: PLACEBO_COMPARATOR

Saline solution

Intervention Type: DRUG

With a syringe, aspirate 2.5 ml of a 0.9% NaCl solution. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

Interventions

Oradexon

With a syringe aspirate 2.5 ml of a 5mg/ml dexamethasone solution, for a total of 12.5mg. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

Intervention Type: DRUG

Ropivacaine

With a syringe aspirate 2.5 ml of a 7.5mg/ml dexamethasone solution, for a total of 18.75mg. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

Intervention Type: DRUG

Saline solution

With a syringe, aspirate 2.5 ml of a 0.9% NaCl solution. Repeat the procedure with another syringe. 2 syringes must be prepared, one for each of the tonsil sites.

Intervention Type: DRUG

Other Intervention Names

dexamethasone

Eligibility 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;

Exclusion Criteria

• Use of chronic analgesic medication;
• ASA III-IV;
• Coagulation disorders, such as von Willebrand disease or diagnosis of other platelet disorders, haemophilia A and B, or diseases that may develop with hemostatic dysfunction;
• Intolerance or allergy to any of the drugs used in the study;
• Suspicious or confirmed diagnosis of neoplastic disease;
• Fever or acute respiratory tract infection in the last 3 weeks;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Academic Center (2CA-Braga)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Menezes

Role: PRINCIPAL_INVESTIGATOR

Serviço de Otorrinolaringologia, Hospital de Braga, EPE

Locations

Serviço de Otorrinolaringologia, Hospital de Braga

Braga, , Portugal

Countries

Portugal

Other Identifiers

2019-000202-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2CA_2019_ORL_01

Identifier Type: -

Identifier Source: org_study_id