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

NCT05504967 | Completed Phase 2

• 2 other identifiers: 2CA_2019_ORL_012019-000202-29
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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

Keywords

Tonsillectomy; Pain management

Outcome Measures

Primary Outcomes (8)

• Change in pain assessment using the VAS

  Alteration in Visual Analogue Scale values (1-100mm) to assess pain at rest and during swallowing

  Change from baseline (90 days before surgery; day of surgery, day 1, 2, 3, 7 and 15 after surgery)

• Time to first administration of analgesia

  Time until it is needed to administer analgesia to the patient, after surgery (in minutes)

  From the day of surgery to discharge (an average 1 day)

• Paracetamol intake

  Number of paracetamol intakes

  Time since the end of surgery until post-operative visit (15 days after surgery)

• Paracetamol cumulative dosage intake

  Cumulative dosage of paracetamol intake in mg

  Time since the end of surgery until post-operative visit (15 days after surgery)

• Rescue analgesia intake

  Number of rescue analgesia intakes (tramadol)

  Time since the end of surgery until post-operative visit (15 days after surgery)

• Need of Pethidine

  Need of pethidine in immediate post-surgery (yes/no)

  Immediate post-surgery

• Time to need of Pethidine

  Time until pethidine admnistration is needed, since the end of surgery (minutes)

  Time since the end of surgery until post-operative visit (15 days after surgery)

• Time to onset of water intake, liquid and solid oral diet

  Time to onset of water intake, liquid and solid oral diet, since the end of surgery (minutes)

  Time since the end of surgery until post-operative visit (15 days after surgery)

Secondary Outcomes (1)

• Safety outcome

  Time since screening until post-operative visit (15 days after surgery)

Study Arms (4)

dexamethasone

ACTIVE COMPARATOR

12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total). Single dosage pre-incisional.

Drug: Oradexon; Drug: Saline solution

ropivacain

ACTIVE COMPARATOR

18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total). Single dosage pre-incisional.

Drug: Ropivacaine; Drug: Saline solution

ropivacain + dexamethasone

EXPERIMENTAL

18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca). Single dosage pre-incisional.

Drug: Oradexon; Drug: Ropivacaine

placebo

PLACEBO COMPARATOR

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.

Drug: Saline solution

Interventions

Oradexon 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.

Also known as: dexamethasone

dexamethasone; ropivacain + dexamethasone

Ropivacaine 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.

ropivacain; ropivacain + dexamethasone

Saline solution 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.

dexamethasone; placebo; ropivacain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Clinical Academic Center (2CA-Braga): lead

Study Sites (1)

Serviço de Otorrinolaringologia, Hospital de Braga

Braga, 4710-243, Portugal

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexamethasone; Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ana Menezes

  Serviço de Otorrinolaringologia, Hospital de Braga, EPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controlled, double-blind clinical trial

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: August 17, 2022
• Study Start: December 22, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

PT (1)