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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tonsillectomy

Intervention / Treatment
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* Drug: Oradexon
* Drug: Ropivacaine
* Drug: Saline solution


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, controlled, double-blind clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone<br>12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total). Single dosage pre-incisional. | Drug: Oradexon<br>* 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.<br>* Other names: dexamethasone;Drug: Saline solution<br>* 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.<br>|
| Active Comparator: ropivacain<br>18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total). Single dosage pre-incisional. | Drug: Ropivacaine<br>* 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.<br>Drug: Saline solution<br>* 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.<br>|
| Experimental: ropivacain + dexamethasone<br>18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca). Single dosage pre-incisional. | Drug: Oradexon<br>* 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.<br>* Other names: dexamethasone;Drug: Ropivacaine<br>* 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.<br>|
| Placebo Comparator: placebo<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcome | Number of adverse events | Time since screening until post-operative visit (15 days after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, Pain management