Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-25 @ 5:44 PM
Study NCT ID:
NCT04110132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2018-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Egypt']}, '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': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant, care provider and outcomes assessors will not be aware of the used intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After approval of local ethical committee and patient consent, this double blinded randomized study will be done on 60 patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.\n\nAfter standard general anesthesia with Propofol 1-2mg/kg LMA for airway management and maintenance with Isoflurane 1%. The patient will be randomized into two groups.\n\nBupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.\n\nSaline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2018-05-05', 'studyFirstSubmitQcDate': '2019-09-28', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 hours', 'description': 'VAS sore 0-10'}], 'secondaryOutcomes': [{'measure': 'First request of pain medications will be measured.', 'timeFrame': '24 hours', 'description': 'Time in hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '27614384', 'type': 'BACKGROUND', 'citation': 'Cardaillac C, Ploteau S, Labat JJ, Levesque A, Riant T. [Interest of infiltration of Impar node in rebel vulvodynia: About a series of 8 cases]. Prog Urol. 2016 Dec;26(17):1213-1221. doi: 10.1016/j.purol.2016.08.004. Epub 2016 Sep 7. French.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the ganglion Impar block in the prevention of postoperative pain after anal surgery.', 'detailedDescription': 'Postoperative analgesia using ganglion Impar block after anal surgery\n\nIntroduction\n\nGanglion Impar block may be used for treatment of chronic perineal pain (1) Aim\n\nThe aim of this study is to evaluate the ganglion Impar block in the prevention of postoperative pain after anal surgery.\n\nPatients and Methods\n\nAfter approval of local ethical committee and patient consent, this double blinded randomized study will be done on 60 patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.\n\nAfter standard general anesthesia with Propofol 1-2mg/kg LMA for airway management and maintenance with Isoflurane 1%. The patient will be randomized into two groups.\n\nBupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.\n\nSaline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Postoperative VAS will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative.\n\nFirst request of pain medications will be measured.\n\nResults Results will be collected in tables and graphs. Appropriate statistical analysis will be done.\n\nDiscussion Results of the study will be discussed compared to other studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.\n\nExclusion Criteria:\n\n* Coagulation effects\n* Allergy to Bupivacaine\n* Previous anal surgery\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT04110132', 'briefTitle': 'Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery', 'orgStudyIdInfo': {'id': '16/70-8/2/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ganglion impar block with Bupivacaine.', 'description': 'Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.\n\nPatient will have hemorrhoidectomy.', 'interventionNames': ['Procedure: Ganglion impar block with Bupivacaine.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ganglion impar block with Saline', 'description': 'Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Patient will have hemorrhoidectomy.', 'interventionNames': ['Procedure: Ganglion impar block with normal saline']}], 'interventions': [{'name': 'Ganglion impar block with Bupivacaine.', 'type': 'PROCEDURE', 'description': 'Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.\n\nPostoperative VAS will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative.', 'armGroupLabels': ['Ganglion impar block with Bupivacaine.']}, {'name': 'Ganglion impar block with normal saline', 'type': 'PROCEDURE', 'description': 'Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Postoperative VAS will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative.', 'armGroupLabels': ['Ganglion impar block with Saline']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammad Hazem I Ahmad Sabry, MD', 'role': 'CONTACT', 'email': 'mohammad_hazem@yahoo.com', 'phone': '+201062718827'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia', 'investigatorFullName': 'Mohammad Hazem I. Ahmad Sabry', 'investigatorAffiliation': 'University of Alexandria'}}}}