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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
115
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.
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.
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.
Serviço de Otorrinolaringologia, Hospital de Braga
Braga, Portugal
Change in pain assessment using the VAS
Alteration in Visual Analogue Scale values (1-100mm) to assess pain at rest and during swallowing
Time frame: 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)
Time frame: From the day of surgery to discharge (an average 1 day)
Paracetamol intake
Number of paracetamol intakes
Time frame: 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 frame: Time since the end of surgery until post-operative visit (15 days after surgery)
Rescue analgesia intake
Number of rescue analgesia intakes (tramadol)
Time frame: 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)
Time frame: Immediate post-surgery
Time to need of Pethidine
Time until pethidine admnistration is needed, since the end of surgery (minutes)
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
Time to onset of water intake, liquid and solid oral diet, since the end of surgery (minutes)
Time frame: Time since the end of surgery until post-operative visit (15 days after surgery)
Safety outcome
Number of adverse events
Time frame: Time since screening until post-operative visit (15 days after surgery)
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