TonsillectomyPhase 2ORLNCT05504967
CT Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine + Dexamethasone in Pain Management After Tonsillectomy
A Phase 2 study testing Oradexon, Ropivacaine and Saline solution in people with Tonsillectomy, run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Oradexon, Ropivacaine and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 sitePortugal
- Study dates
- 22 Dec 2020to 1 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Serviço de Otorrinolaringologia, Hospital de Braga
Braga, 4710-243
About this study
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
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.
Read more
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.
- Conditions
- Tonsillectomy
- Being tested
- Oradexon, Ropivacaine, Saline solution
- Keywords
- Tonsillectomy, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OradexonDrug
Also called dexamethasone
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.
RopivacaineDrug
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 solutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | Active comparator | 12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total).
Single dosage pre-incisional. Receives: Drug: Oradexon; Drug: Saline solution |
| ropivacain | Active comparator | 18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total).
Single dosage pre-incisional. Receives: Drug: Ropivacaine; Drug: Saline solution |
| ropivacain + dexamethasone | Experimental | 18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca).
Single dosage pre-incisional. Receives: Drug: Oradexon; Drug: Ropivacaine |
| placebo | Placebo comparator | 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. Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain assessment using the VAS
Alteration in Visual Analogue Scale values (1-100mm) to assess pain at rest and during swallowing
Measured: 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)
Measured: From the day of surgery to discharge (an average 1 day)
Paracetamol intake
Number of paracetamol intakes
Measured: 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
Measured: Time since the end of surgery until post-operative visit (15 days after surgery)
Rescue analgesia intake
Number of rescue analgesia intakes (tramadol)
Measured: 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)
Measured: Immediate post-surgery
Time to need of Pethidine
Time until pethidine admnistration is needed, since the end of surgery (minutes)
Measured: 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)
Measured: Time since the end of surgery until post-operative visit (15 days after surgery)
Secondary outcomes (1)
Safety outcome
Number of adverse events
Measured: Time since screening until post-operative visit (15 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start22 Dec 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, double-blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Academic Center (2CA-Braga)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Menezes, Principal investigator, Serviço de Otorrinolaringologia, Hospital de Braga, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504967
- Sponsor's protocol ID
- 2CA_2019_ORL_01
- Other IDs
- 2019-000202-29, 2019
- Acronym
- ORL
- Status last verified
- Aug 2025
- First submitted
- 26 May 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05504967
- Acronym / sponsor ID
- ORL / 2CA_2019_ORL_01
- Conditions
- Tonsillectomy
- Keywords
- Tonsillectomy, Pain management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Clinical Academic Center (2CA-Braga)University, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized, controlled, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Active comparator | Drug: Oradexon, Drug: Saline solution12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total). Single dosage pre-incisional. |
| ropivacain | Active comparator | Drug: Ropivacaine, Drug: Saline solution18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total). Single dosage pre-incisional. |
| ropivacain + dexamethasone | Experimental | Drug: Oradexon, Drug: Ropivacaine18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca). Single dosage pre-incisional. |
| placebo | Placebo comparator | Drug: Saline solutionSaline 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OradexonAlso: dexamethasoneWith 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. | Drug | dexamethasone, ropivacain + dexamethasone |
| RopivacaineWith 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. | Drug | ropivacain, ropivacain + dexamethasone |
| Saline solutionWith 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. | Drug | dexamethasone, placebo, ropivacain |
Primary outcome
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 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
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)
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)
1 secondary outcome
Safety outcome
Time frame: Time since screening until post-operative visit (15 days after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Menezes principal investigator
Serviço de Otorrinolaringologia, Hospital de Braga, EPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oradexon, Ropivacaine and Saline solution in people with Tonsillectomy, run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.