Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-01 @ 5:24 PM
Study NCT ID:
NCT05504967
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine + Dexamethasone in Pain Management After Tonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, controlled, double-blind clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': 'Alteration in Visual Analogue Scale values (1-100mm) to assess pain at rest and during swallowing'}, {'measure': 'Time to first administration of analgesia', 'timeFrame': 'From the day of surgery to discharge (an average 1 day)', 'description': 'Time until it is needed to administer analgesia to the patient, after surgery (in minutes)'}, {'measure': 'Paracetamol intake', 'timeFrame': 'Time since the end of surgery until post-operative visit (15 days after surgery)', 'description': 'Number of paracetamol intakes'}, {'measure': 'Paracetamol cumulative dosage intake', 'timeFrame': 'Time since the end of surgery until post-operative visit (15 days after surgery)', 'description': 'Cumulative dosage of paracetamol intake in mg'}, {'measure': 'Rescue analgesia intake', 'timeFrame': 'Time since the end of surgery until post-operative visit (15 days after surgery)', 'description': 'Number of rescue analgesia intakes (tramadol)'}, {'measure': 'Need of Pethidine', 'timeFrame': 'Immediate post-surgery', 'description': 'Need of pethidine in immediate post-surgery (yes/no)'}, {'measure': 'Time to need of Pethidine', 'timeFrame': 'Time since the end of surgery until post-operative visit (15 days after surgery)', 'description': 'Time until pethidine admnistration is needed, since the end of surgery (minutes)'}, {'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)', 'description': 'Time to onset of water intake, liquid and solid oral diet, since the end of surgery (minutes)'}], 'secondaryOutcomes': [{'measure': 'Safety outcome', 'timeFrame': 'Time since screening until post-operative visit (15 days after surgery)', 'description': 'Number of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tonsillectomy', 'Pain management'], 'conditions': ['Tonsillectomy']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nApproximately 104 individuals, aged 18 to 65 years, proposed for tonsillectomy will be included in the study, i.e., 26 subjects in each study group.\n\nPostoperative 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-II;\n* Surgical proposal of tonsillectomy;\n* Tonsillectomy performed by the cold shedding technique;\n* History of recurrent tonsillitis, caseous tonsillitis and / or peritonsillar abscess;\n\nExclusion Criteria:\n\n* Use of chronic analgesic medication;\n* ASA III-IV;\n* 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;\n* Intolerance or allergy to any of the drugs used in the study;\n* Suspicious or confirmed diagnosis of neoplastic disease;\n* Fever or acute respiratory tract infection in the last 3 weeks;'}, 'identificationModule': {'nctId': 'NCT05504967', 'acronym': 'ORL', 'briefTitle': 'CT Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine + Dexamethasone in Pain Management After Tonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Academic Center (2CA-Braga)'}, 'officialTitle': 'Single-center, Double-blind, Placebo-controlled Study Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine and Dexamethasone for Pain Management After Tonsillectomy', 'orgStudyIdInfo': {'id': '2CA_2019_ORL_01'}, 'secondaryIdInfos': [{'id': '2019-000202-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexamethasone', 'description': '12.5mg dexamethasone + saline solution peramygdalin infiltration in each loca (25mg in total).\n\nSingle dosage pre-incisional.', 'interventionNames': ['Drug: Oradexon', 'Drug: Saline solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ropivacain', 'description': '18.75 mg ropivacain + saline solution peramygdalin infiltration in each loca (37mg in total).\n\nSingle dosage pre-incisional.', 'interventionNames': ['Drug: Ropivacaine', 'Drug: Saline solution']}, {'type': 'EXPERIMENTAL', 'label': 'ropivacain + dexamethasone', 'description': '18.75mg ropivacain + 12.5mg dexamethasone peramygdalin infiltration (in each loca).\n\nSingle dosage pre-incisional.', 'interventionNames': ['Drug: Oradexon', 'Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '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.', 'interventionNames': ['Drug: Saline solution']}], 'interventions': [{'name': 'Oradexon', 'type': 'DRUG', 'otherNames': ['dexamethasone'], 'description': '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.', 'armGroupLabels': ['dexamethasone', 'ropivacain + dexamethasone']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['ropivacain', 'ropivacain + dexamethasone']}, {'name': 'Saline solution', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['dexamethasone', 'placebo', 'ropivacain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4710-243', 'city': 'Braga', 'country': 'Portugal', 'facility': 'Serviço de Otorrinolaringologia, Hospital de Braga', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}], 'overallOfficials': [{'name': 'Ana Menezes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Serviço de Otorrinolaringologia, Hospital de Braga, EPE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Academic Center (2CA-Braga)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}