Single-center, Double-blind, Placebo-controlled Study Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine and Dexamethasone for Pain Management After Tonsillectomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Time to first administration of analgesia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
dexamethasone
12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total).
Single dosage pre-incisional.
Intervention: Oradexon (Drug)
dexamethasone
12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total).
Single dosage pre-incisional.
Intervention: Saline solution (Drug)
ropivacain
18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total).
Single dosage pre-incisional.
Intervention: Ropivacaine (Drug)
ropivacain
18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total).
Single dosage pre-incisional.
Intervention: Saline solution (Drug)
ropivacain + dexamethasone
18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca).
Single dosage pre-incisional.
Intervention: Oradexon (Drug)
ropivacain + dexamethasone
18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca).
Single dosage pre-incisional.
Intervention: Ropivacaine (Drug)
placebo
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.
Intervention: Saline solution (Drug)
Outcomes
Primary Outcomes
Time to first administration of analgesia
Time Frame: 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 Frame: 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
Time Frame: 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 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, since the end of surgery (minutes)
Paracetamol cumulative dosage intake
Time Frame: 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 Frame: Time since the end of surgery until post-operative visit (15 days after surgery)
Number of rescue analgesia intakes (tramadol)
Need of Pethidine
Time Frame: Immediate post-surgery
Need of pethidine in immediate post-surgery (yes/no)
Time to need of Pethidine
Time Frame: 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 Outcomes
- Safety outcome(Time since screening until post-operative visit (15 days after surgery))