Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 11:23 PM
Study NCT ID:
NCT06886568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Ganglion Impar Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Injection accuracy', 'timeFrame': 'Post-procedure 1st hour', 'description': 'In all patients, the sacrococcygeal or transcoccygeal space will be identified under ultrasound guidance. A 22-gauge spinal needle will be advanced into the joint space under ultrasound visualization. Using a saline-filled syringe, the loss-of-resistance technique will be employed to confirm passage through the joint space and entry into the retroperitoneal space. Subsequently, a lateral fluoroscopic image will be obtained, and contrast medium will be injected to verify needle placement. If appropriate contrast dispersion is observed along the midline, the procedure will be considered successful, and the medication will be administered. If contrast distribution is inadequate (e.g. vascular spread, non-midline spread), the procedure will be discontinued under ultrasound guidance and resumed under fluoroscopic guidance.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'Baseline, 1st hour, 1st week, 1st month', 'description': 'Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 10-point scale where 1 indicates no pain and 10 represents the worst pain.'}, {'measure': 'Pain-free sitting duration', 'timeFrame': 'Baseline, 1st hour, 1st week, 1st month', 'description': 'Pain-free sitting duration (minutes) will be recorded.'}, {'measure': 'The number of attempts', 'timeFrame': 'Post-procedure 1st hour', 'description': 'The number of attempts will be recorded.'}, {'measure': 'Technical difficulty of injection', 'timeFrame': 'Post-procedure 1st hour', 'description': 'The technical difficulty of the injection will be assessed using a 10-item scale, where 1 indicates no difficulty and 10 represents the highest level of difficulty'}, {'measure': 'Complications', 'timeFrame': 'Baseline, 1st hour, 1st week, 1st month', 'description': 'All complications following the injection will be recorded, including infections, bleeding, hematoma, allergic reactions, steroid-related complications, transient hypoesthesia, and weakness, among others.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coccydynia', 'pain', 'ultrasound guided injection', 'ganglion impar'], 'conditions': ['Coccydynia', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '33850934', 'type': 'BACKGROUND', 'citation': 'Li SQ, Jiang L, Cui LG, Jia DL. Clinical efficacy of ultrasound-guided pulsed radiofrequency combined with ganglion impar block for treatment of perineal pain. World J Clin Cases. 2021 Mar 26;9(9):2153-2159. doi: 10.12998/wjcc.v9.i9.2153.'}, {'pmid': '31007658', 'type': 'BACKGROUND', 'citation': 'Ghai A, Jangra P, Wadhera S, Kad N, Karwasra RK, Sahu A, Jaiswal R. A prospective study to evaluate the efficacy of ultrasound-guided ganglion impar block in patients with chronic perineal pain. Saudi J Anaesth. 2019 Apr-Jun;13(2):126-130. doi: 10.4103/sja.SJA_667_18.'}, {'pmid': '20447308', 'type': 'BACKGROUND', 'citation': 'Lin CS, Cheng JK, Hsu YW, Chen CC, Lao HC, Huang CJ, Cheng PH, Narouze S. Ultrasound-guided ganglion impar block: a technical report. Pain Med. 2010 Mar;11(3):390-4. doi: 10.1111/j.1526-4637.2010.00797.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate feasibility, reliability and short term effectiveness of ganglion impar block with ultrasound in patients with chronic coccygodinia.', 'detailedDescription': 'Ganglion impar blocks have long been used for coccydynia, either with a landmark-based technique or fluoroscopic guidance. With the growing use of ultrasound, ultrasound-guided ganglion impar block has become a viable alternative.\n\nDespite its frequent use in clinical practice, ultrasound has limitations in visualizing structures behind the bone, while fluoroscopy remains the gold standard. Further research is needed to evaluate its feasibility, safety, and efficacy.\n\nThis study primarily aims to assess the feasibility and safety of ultrasound-guided ganglion impar block in coccydynia. Additionally, it will examine its short-term (1-month) efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-65 years.\n* Coccydynia persisting for at least three months.\n* Being scheduled for a ganglion impar block in the pain medicine outpatient clinic.\n* Having inadequate response to medical and conservative treatments.\n* Aggreeing to undergo the interventional procedure and participate in the study.\n\nExclusion Criteria:\n\n* Local infection at the injection site.\n* Bleeding disorders or diseases and drugs that may cause bleeding diatesis (e.g. renal failure, liver failure, anticoagulant treatments)\n* History of allergic reaction to the medications to be used.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06886568', 'briefTitle': 'Ultrasound Guided Ganglion Impar Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'Ultrasound Guided Ganglion Impar Block', 'orgStudyIdInfo': {'id': '2022.03.98'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injection Group', 'description': 'Ganglion impar block will be applied under ultrasound guidance', 'interventionNames': ['Procedure: Ultrasound-guided ganglion impar block']}], 'interventions': [{'name': 'Ultrasound-guided ganglion impar block', 'type': 'PROCEDURE', 'description': 'The procedure will be performed under sterile conditions and continuous monitoring. Using an ultrasound device with a 10-12 MHz linear probe, a 22G spinal needle will be advanced into the sacrococcygeal joint space using the out-of-plane technique. After confirming loss of resistance with a syringe containing normal saline as the needle exits the capsule anterior to the joint, approximately 1 mL of contrast medium will be injected. Anteroposterior (AP) and lateral fluoroscopic images will be obtained to verify the spread of the contrast agent. Once adequate contrast distribution is confirmed anterior to the coccyx on the lateral view, a mixture of dexamethasone and bupivacaine will be injected to complete the block. Procedures that cannot be completed or successfully visualized under ultrasound guidance will be finalized under fluoroscopic guidance.', 'armGroupLabels': ['Injection Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Başakşehir', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tuba Tanyel Saraçoğlu, MD', 'role': 'CONTACT', 'email': 'tuba.saracoglu1@saglik.gov.tr', 'phone': '+0905396210136'}, {'name': 'Duygu Karali-Bingül, MD', 'role': 'CONTACT', 'email': 'd_karali@yahoo.com'}], 'facility': 'Başakşehir Çam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Tuba Tanyel Saraçoğlu, MD', 'role': 'CONTACT', 'email': 'tuba.saracoglu1@saglik.gov.tr', 'phone': '00902129096000', 'phoneExt': '30721'}, {'name': 'Duygu Karali-Bingul, MD', 'role': 'CONTACT', 'email': 'd_karali@yahoo.com'}], 'overallOfficials': [{'name': 'Duygu Karali-Bingul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Başakşehir Çam & Sakura City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Head of Algology Department', 'investigatorFullName': 'Tuba Tanyel Saraçoğlu', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}