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

Phase 2

• Conditions: Tonsillectomy
• Interventions: Drug: Oradexon; Drug: Ropivacaine; Drug: Saline solution

• Registration Number: NCT05504967
• Lead Sponsor: Clinical Academic Center (2CA-Braga)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2022-05-26
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-17
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacain + dexamethasone	Oradexon	18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca). Single dosage pre-incisional.
ropivacain	Ropivacaine	18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total). Single dosage pre-incisional.
dexamethasone	Saline solution	12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total). Single dosage pre-incisional.
dexamethasone	Oradexon	12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total). Single dosage pre-incisional.
placebo	Saline solution	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.
ropivacain	Saline solution	18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total). Single dosage pre-incisional.
ropivacain + dexamethasone	Ropivacaine	18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca). Single dosage pre-incisional.

Primary Outcome Measures

Name	Time	Method
Time to first administration of analgesia	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)
Paracetamol intake	Time since the end of surgery until post-operative visit (15 days after surgery)	Number of paracetamol intakes
Change in pain assessment using the VAS	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
Time to onset of water intake, liquid and solid oral diet	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)
Paracetamol cumulative dosage intake	Time since the end of surgery until post-operative visit (15 days after surgery)	Cumulative dosage of paracetamol intake in mg
Rescue analgesia intake	Time since the end of surgery until post-operative visit (15 days after surgery)	Number of rescue analgesia intakes (tramadol)
Need of Pethidine	Immediate post-surgery	Need of pethidine in immediate post-surgery (yes/no)
Time to need of Pethidine	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)

Secondary Outcome Measures

Name	Time	Method
Safety outcome	Time since screening until post-operative visit (15 days after surgery)	Number of adverse events

Trial Locations

Locations (1)

Serviço de Otorrinolaringologia, Hospital de Braga; 🇵🇹 Braga, Portugal