Clinical trial NCT05504967: CT Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine + Dexamethasone in Pain Management After Tonsillectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tonsillectomy
Keywords: Tonsillectomy
Pain management
Lead sponsor: Clinical Academic Center (2CA-Braga)
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled, double-blind clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change in pain assessment using the VAS
timeFrame: Change from baseline (90 days before surgery; day of surgery, day 1, 2, 3, 7 and 15 after surgery)
measure: Time to first administration of analgesia
timeFrame: From the day of surgery to discharge (an average 1 day)
measure: Paracetamol intake
timeFrame: Time since the end of surgery until post-operative visit (15 days after surgery)
measure: Paracetamol cumulative dosage intake
timeFrame: Time since the end of surgery until post-operative visit (15 days after surgery)
measure: Rescue analgesia intake
timeFrame: Time since the end of surgery until post-operative visit (15 days after surgery)
measure: Need of Pethidine
timeFrame: Immediate post-surgery
measure: Time to need of Pethidine
timeFrame: Time since the end of surgery until post-operative visit (15 days after surgery)
measure: Time to onset of water intake, liquid and solid oral diet
timeFrame: Time since the end of surgery until post-operative visit (15 days after surgery)
Secondary outcomes:
measure: Safety outcome
timeFrame: Time since screening until post-operative visit (15 days after surgery)
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Serviço de Otorrinolaringologia, Hospital de Braga
Study officials:
affiliation: Serviço de Otorrinolaringologia, Hospital de Braga, EPE
name: Ana Menezes
role: PRINCIPAL_INVESTIGATOR
References: