Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 2:40 PM
Study NCT ID:
NCT05435833
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2022-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2022-06-18', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of 1st analgesic request', 'timeFrame': 'up to 24 hours postoperative', 'description': 'the time to first analgesic request will be recorded'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperative', 'description': 'The numerical rating scale for pain ranging from 0-10 where the minimum value of 0 represents no pain and the maximum value of 10 represent the worst pain imaginable'}, {'measure': 'Postoperative rescue analgesic consumption', 'timeFrame': 'up to 24hours postoperative', 'description': 'Total 24 hours postoperative rescue analgesic consumption'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'referencesModule': {'references': [{'pmid': '28890114', 'type': 'BACKGROUND', 'citation': 'Kim MS, Choi HG, Park EK, Kim SY, Kim JH, Park B. Natural course of tonsillectomy pain: A prospective patient cohort study. Auris Nasus Larynx. 2018 Jun;45(3):508-513. doi: 10.1016/j.anl.2017.07.018. Epub 2017 Sep 8.'}, {'pmid': '31341828', 'type': 'BACKGROUND', 'citation': 'Ahmed SA, Omara AF. The Effect of Glossopharyngeal Nerve Block on Post-Tonsillectomy Pain of Children; Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 30;9(2):e90854. doi: 10.5812/aapm.90854. eCollection 2019 Apr.'}, {'pmid': '16238560', 'type': 'BACKGROUND', 'citation': 'Ozalevli M, Unlugenc H, Tuncer U, Gunes Y, Ozcengiz D. Comparison of morphine and tramadol by patient-controlled analgesia for postoperative analgesia after tonsillectomy in children. Paediatr Anaesth. 2005 Nov;15(11):979-84. doi: 10.1111/j.1460-9592.2005.01591.x.'}, {'pmid': '16211736', 'type': 'BACKGROUND', 'citation': 'Naesh O, Niles LA, Gilbert JG, Ammar MM, Phibbs PW, Phillips AM, Khrapov AV, Robert AJ, McClintock A. A randomized, placebo-controlled study of rofecoxib with paracetamol in early post-tonsillectomy pain in adults. Eur J Anaesthesiol. 2005 Oct;22(10):768-73. doi: 10.1017/s0265021505001274.'}, {'pmid': '15313860', 'type': 'BACKGROUND', 'citation': 'Hanasono MM, Lalakea ML, Mikulec AA, Shepard KG, Wellis V, Messner AH. Perioperative steroids in tonsillectomy using electrocautery and sharp dissection techniques. Arch Otolaryngol Head Neck Surg. 2004 Aug;130(8):917-21. doi: 10.1001/archotol.130.8.917.'}, {'pmid': '12791448', 'type': 'BACKGROUND', 'citation': 'Kaygusuz I, Susaman N. The effects of dexamethasone, bupivacaine and topical lidocaine spray on pain after tonsillectomy. Int J Pediatr Otorhinolaryngol. 2003 Jul;67(7):737-42. doi: 10.1016/s0165-5876(03)00091-0.'}, {'pmid': '16193589', 'type': 'BACKGROUND', 'citation': 'Ginstrom R, Silvola J, Saarnivaara L. Local bupivacaine-epinephrine infiltration combined with general anesthesia for adult tonsillectomy. Acta Otolaryngol. 2005 Sep;125(9):972-5. doi: 10.1080/00016480510043413.'}, {'pmid': '33201518', 'type': 'BACKGROUND', 'citation': 'Aldamluji N, Burgess A, Pogatzki-Zahn E, Raeder J, Beloeil H; PROSPECT Working Group collaborators*. PROSPECT guideline for tonsillectomy: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Jul;76(7):947-961. doi: 10.1111/anae.15299. Epub 2020 Nov 17.'}, {'pmid': '31221427', 'type': 'BACKGROUND', 'citation': 'Tolska HK, Hamunen K, Takala A, Kontinen VK. Systematic review of analgesics and dexamethasone for post-tonsillectomy pain in adults. Br J Anaesth. 2019 Aug;123(2):e397-e411. doi: 10.1016/j.bja.2019.04.063. Epub 2019 Jun 17.'}, {'pmid': '32132800', 'type': 'BACKGROUND', 'citation': 'Sirohiya P, Kumar V, Yadav P, Bharti SJ. Ultrasound-Guided Glossopharyngeal Nerve Block at Pharyngeal Wall Level in a Patient with Carcinoma Tongue. Indian J Palliat Care. 2020 Jan-Mar;26(1):140-141. doi: 10.4103/IJPC.IJPC_132_19. Epub 2020 Jan 28.'}, {'pmid': '31333392', 'type': 'BACKGROUND', 'citation': 'Manoharan D, Bharati SJ, Yadav MK. A novel technique of ultrasound-guided glossopharyngeal nerve block to relieve cancer pain. Saudi J Anaesth. 2019 Jul-Sep;13(3):279-280. doi: 10.4103/sja.SJA_139_19. No abstract available.'}, {'pmid': '9174298', 'type': 'BACKGROUND', 'citation': 'Bean-Lijewski JD. Glossopharyngeal nerve block for pain relief after pediatric tonsillectomy: retrospective analysis and two cases of life-threatening upper airway obstruction from an interrupted trial. Anesth Analg. 1997 Jun;84(6):1232-8. doi: 10.1097/00000539-199706000-00011.'}, {'pmid': '28195898', 'type': 'BACKGROUND', 'citation': 'Azman J, Stopar Pintaric T, Cvetko E, Vlassakov K. Ultrasound-Guided Glossopharyngeal Nerve Block: A Cadaver and a Volunteer Sonoanatomy Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):252-258. doi: 10.1097/AAP.0000000000000561.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the efficacy and safety of Ultra-sound guided submandibular parapharyngeal glossopharyngeal nerve block as regards time for first need of analgesic as a primary outcome as well as pain score, total postoperative analgesic requirement, and incidence of complications as secondary outcomes', 'detailedDescription': 'Tonsillectomy is one of the most frequent surgical procedures performed all over the world that has been identified as being severely painful especially in the adult population. Management of post tonsillectomy pain is of paramount importance in order to improve swallowing and enhance oral intake as well as to decrease the risk of dehydration, infection and secondary hemorrhage with a subsequent hastening of recovery.\n\nA variety of analgesic regimens have been implemented to alleviate post-tonsillectomy pain, however; no consensus on the ideal analgesic regimen has been yet identified.\n\nThe Ultrasound (US)-guided glossopharyngeal nerve (GPN) block has been acknowledged as a feasible option for providing perioperative analgesia in tonsillectomy patients. It blocks sensory impulses from the posterior third of the tongue, palatine tonsil, and mucous membranes of the mouth and pharynx. Conventional techniques for blocking the GPN carry the risk of vascular puncture, inadvertent block of closely adjacent other cranial nerves, with increased probability of local anesthetic toxicity and even upper airway obstruction. Recently, a novel, safe, and reproducible US-guided GPN block technique has been introduced by Azman et al, which would block the GPN distally, in the tissue plane just next to the pharyngeal wall and relatively far from high risk nearby structures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients classified by the American society of Anesthesiologists ASA I and II patients\n* Scheduled for tonsillectomy procedure\n\nExclusion Criteria:\n\n* Patients' refusal\n* History of diabetes mellitus,\n* Cardiac, liver or renal impairment\n* Obstructive sleep apnea syndrome\n* Swallowing difficulty\n* Intake of chronic pain medications or substance abuse\n* Bleeding disorders\n* Hypersensitivity to the used medication"}, 'identificationModule': {'nctId': 'NCT05435833', 'briefTitle': 'Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Ultrasound-Guided Submandibular Parapharyngeal Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief in Adults. A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'GPN block in tonsillectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (glossopharyngeal nerve block group)', 'description': 'bilateral ultrasound guided GPN block will be performed after induction of anesthesia and pre incisional by an experienced anesthesiologist', 'interventionNames': ['Procedure: bilateral ultrasound guided GPN block']}, {'type': 'NO_INTERVENTION', 'label': 'Group II(Control group)', 'description': 'general anesthesia alone (no block)'}], 'interventions': [{'name': 'bilateral ultrasound guided GPN block', 'type': 'PROCEDURE', 'description': 'a linear high frequency ultrasound probe will be initially positioned over the hyoid bone in the transverse plane, then the probe will be rotated to keep in line with the mandibular angle and the pharyngeal wall is identified by US. Using an in plane approach, a 22 G ,5 cm needle will be advanced till it reaches just superficial to the pharyngeal wall and 2.2 ml of 0.25% bupivacaine will be injected.', 'armGroupLabels': ['Group I (glossopharyngeal nerve block group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31599', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Tanta University Hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Mona B El Mourad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gehan Morsy Eid', 'class': 'UNKNOWN'}, {'name': 'Aliaa Muhammad Belal', 'class': 'UNKNOWN'}, {'name': 'Mohamed Shebl Abdelghany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Anesthesia, Surgical Intensive Care and Pain Medicine', 'investigatorFullName': 'Mona Blough El Mourad', 'investigatorAffiliation': 'Tanta University'}}}}