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

Tonsillectomy Clinical Trial

— ORL  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504967
• Other study ID #: 2CA_2019_ORL_01
• Secondary ID: 2019-000202-29
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2020
• Est. completion date: June 2024

Study information

• Verified date: August 2022
• Source: Clinical Academic Center (2CA-Braga)
• Contact: Monica Goncalves
• Phone: +351 253 027 249
• Email: cro[@]ccabraga.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Portugal	Serviço de Otorrinolaringologia, Hospital de Braga	Braga

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Academic Center (2CA-Braga)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Paracetamol intake	Number of paracetamol intakes	Time since the end of surgery until post-operative visit (15 days after surgery)
Primary	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)
Primary	Rescue analgesia intake	Number of rescue analgesia intakes (tramadol)	Time since the end of surgery until post-operative visit (15 days after surgery)
Primary	Need of Pethidine	Need of pethidine in immediate post-surgery (yes/no)	Immediate post-surgery
Primary	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)
Primary	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	Safety outcome	Number of adverse events	Time since screening until post-operative visit (15 days after surgery)