Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-31 @ 7:48 AM
Study NCT ID:
NCT03806335
Status:
SUSPENDED
Last Update Posted:
2022-01-18
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Lack of patients', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain', 'timeFrame': 'within 10 days after the operation', 'description': 'Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10.'}], 'secondaryOutcomes': [{'measure': 'PONV', 'timeFrame': 'within 10 days after the operation', 'description': 'Post operative nausea and vomiting (PONV) will be assessed through a questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.', 'detailedDescription': 'The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with total or partial tonsillectomy with or without adenoidectomy\n\nExclusion Criteria:\n\n* patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma\n* patients who have diabetes\n* patients who have bleeding problems\n* patients who are suspected to have signs of acute pharyngeal infection'}, 'identificationModule': {'nctId': 'NCT03806335', 'briefTitle': 'The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Makassed General Hospital'}, 'officialTitle': 'The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': '32015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infiltration', 'description': 'Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.', 'interventionNames': ['Other: Infiltration', 'Other: General anesthesia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.', 'interventionNames': ['Other: Placebo', 'Other: General anesthesia']}], 'interventions': [{'name': 'Infiltration', 'type': 'OTHER', 'description': 'The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 2.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 10 ml xylocaine 2% an d10 ml bupivacaine 0.5%', 'armGroupLabels': ['Infiltration']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Patients will receive 2.5 ml normal saline in each tonsil', 'armGroupLabels': ['Placebo']}, {'name': 'General anesthesia', 'type': 'OTHER', 'description': 'All patients will receive general anesthesia prior to infiltration', 'armGroupLabels': ['Infiltration', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Makassed General Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Zoher Naja', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makassed General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makassed General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Zoher Naja', 'investigatorAffiliation': 'Makassed General Hospital'}}}}