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NCT Number: NCT05504967

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Serviço de Otorrinolaringologia, Hospital de Braga

Braga, 4710-243, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Other names: 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.

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.

Primary outcomes

  1. Change in pain assessment using the VAS

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

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

  2. Time to first administration of analgesia

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

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

  3. Paracetamol intake

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

    Number of paracetamol intakes

  4. Paracetamol cumulative dosage intake

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

    Cumulative dosage of paracetamol intake in mg

  5. Rescue analgesia intake

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

    Number of rescue analgesia intakes (tramadol)

  6. Need of Pethidine

    Time frame: Immediate post-surgery

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

  7. Time to need of Pethidine

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

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

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

    Time frame: 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, since the end of surgery (minutes)

Secondary outcomes

  1. Safety outcome

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

    Number of adverse events

Sponsors and collaborators

Lead sponsor

Clinical Academic Center (2CA-Braga)

Other

Registry information

Official study title

Single-center, Double-blind, Placebo-controlled Study Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine and Dexamethasone for Pain Management After Tonsillectomy

Acronym: ORL

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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