Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT07246694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced Recovery After Uvulopalatoplasty
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The recovery time', 'timeFrame': '1 hour', 'description': 'The time from from inhalational anesthetic discontinuation to the first response to verbal command.'}], 'secondaryOutcomes': [{'measure': 'Additional intraoperative analgesia', 'timeFrame': '4 hours', 'description': 'Additional doses of intraoperative fentanyl.'}, {'measure': 'Postoperative pain assessment', 'timeFrame': 'The first 24 hours postoperative.', 'description': 'Postoperative pain assessment by the 10 points Visual Analogue Scale at at rest and during swallowing with 0 indicates no pain and 10 indicates the worst pain.'}, {'measure': 'Total rescue analgesia', 'timeFrame': 'The first 24 hours postoperative.', 'description': 'Total rescue analgesic dose needed during the first postoperative 24 hours.'}, {'measure': 'Incidence of complications', 'timeFrame': '4 hours', 'description': 'Incidence of any complications related to nerve block or local anesthesia such as hematoma formation or local anesthetic systemic toxicity.'}, {'measure': 'Quality of recovery', 'timeFrame': 'The first 24 hours postoperative.', 'description': 'Quality of recovery assessed by the Quality of recovery score-15 at the end of the first 24 hours postoperative. The Quality of recovery score ranges from 0 to150, with higher scores indicate better recovery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Recovery, Psychological']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea is a prevalent condition often treated surgically with palatoplasty, which improves airway patency and reduces apneic events. However, postoperative pain and airway discomfort following palatoplasty can be significant, leading to delayed oral intake, increased opioid consumption, and prolonged recovery. Combining an ultrasound-guided glossopharyngeal nerve block with topical airway anesthesia may provide synergistic analgesia and support a safer recovery profile.', 'detailedDescription': 'Obstructive sleep apnea is a prevalent condition often treated surgically with palatoplasty, which improves airway patency and reduces apneic events. However, postoperative pain and airway discomfort following palatoplasty can be significant, leading to delayed oral intake, increased opioid consumption, and prolonged recovery. Enhanced Recovery After Surgery protocols aim to accelerate functional recovery and reduce perioperative morbidity. Combining an ultrasound-guided glossopharyngeal nerve block with topical airway anesthesia may provide effective analgesia and support a smoother recovery profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of moderate to severe obstructive sleep apnea.\n* Patients scheduled for elective palatoplasty under general anesthesia.\n* American Society of Anesthesiologists Physical Status class I and II.\n\nExclusion Criteria:\n\n* Patients with chronic opioid use.\n* Advanced hepatic, renal, cardiovascular, and neurologic diseases.'}, 'identificationModule': {'nctId': 'NCT07246694', 'briefTitle': 'Enhanced Recovery After Uvulopalatoplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Combined Glossopharyngeal Nerve Block With Topical Anesthesia for Enhanced Recovery in Obstructive Sleep Apnea Patients Undergoing Uvulopalatoplasty', 'orgStudyIdInfo': {'id': 'Uvulopalatoplasty Analgesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'The patient will receive the ultrasound-guided glossopharyngeal nerve block combined with topical airway anesthesia.', 'interventionNames': ['Procedure: Glossopharyngeal nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group c', 'description': 'The patient will receive the standard multimodal analgesia.', 'interventionNames': ['Other: Standard multimodal analgesia']}], 'interventions': [{'name': 'Glossopharyngeal nerve block', 'type': 'PROCEDURE', 'description': 'Glossopharyngeal nerve block using ultrasound guidance after induction of general anesthesia plus topical anesthesia before surgical incision.', 'armGroupLabels': ['Group I']}, {'name': 'Standard multimodal analgesia', 'type': 'OTHER', 'description': 'The patient will receive intravenous fentanyl and non opioids analgesics (acetaminophen and non-steroidal anti-inflammatory drugs) with general anesthesia.', 'armGroupLabels': ['Group c']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Al-Sharkia', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Gaber, MD', 'role': 'CONTACT', 'email': 'mgaber200098@gmail.com', 'phone': '01118851696'}, {'name': 'Fatma mahmoud Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Osama Yehia Khalifa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alshaimaa Abdelfattah Kamel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zagazig university hospital', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'Mohamed', 'role': 'CONTACT', 'email': 'mgaber200098@gmail.com', 'phone': '011118851696'}, {'name': 'Osama Yehia, MD', 'role': 'CONTACT', 'phone': '01007579438'}], 'overallOfficials': [{'name': 'Fatma Mahmoud Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia, Intensive Care & Pain Management, Zagazig University'}, {'name': 'Alshaimaa Abdelfattah Kamel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesia, Intensive Care & Pain Management, Zagazig University'}, {'name': 'Osama Yehia Khalifa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesia, Intensive Care & Pain Management, Zagazig University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}