Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-31 @ 9:38 PM
Study NCT ID:
NCT05427058
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2022-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Participant and Investigator masking:\n\nThe random order of the groups will be written on paper and hidden by using a sealed envelope with consecutive numbers. This envelope will be retained by personnel who are not involved in the care or evaluation of the patient, or the analysis of the data.\n\nDuring the action, doctors and nurses are prohibited from communicating with participants regarding the actions given.\n\nOutcomes assessor masking:\n\nAll data collection will be carried out by residents as research assistants who are trained for data collection. The assistant was not told what intervention was given to the patient, data collection was done directly by asking the patient without looking at the patient's status. The data that has been collected will be entered and processed by personnel outside the research team to ensure blinding."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were assigned to two groups.\n\nGroup 1: Patients with pelvic floor pain due to cervical and endometrial cancer who were treated with superior hypogastric plexus block.\n\nGroup 2: Patients with pelvic floor pain due to cervical and endometrial cancer who were given ganglion impar block.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical rating scale (NRS)', 'timeFrame': '3 month', 'description': 'Used to measure pain relief with a value of 0-10 (0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = most severe pain). The average pain intensity felt by the patient in the last 1 week'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '3 Month', 'description': 'The Oswestry Disability Index is a measuring tool to evaluate the quality of life and the level of disability. In this study, we will use the Indonesian adaptation version. in a journal published by Phedy et al showed that the Indonesian version of the ODI retains the reliability, validity, and psychometric characteristics of the original ODI.\n\nThere are 10 main questions with 6 assessment options from the lowest point of 0 and the highest point of 5.\n\n0-20%: mild disability 21-40%: moderate disability, affecting activities can still be overcome 41-60%: severe disability, pain is a major problem and interferes with activities 61-80%: patients experience disturbances in major aspects of life requiring intervention 81-100%: the patient is confined to bed because of complaints'}, {'measure': 'Morphine equivalent daily dose (MEDD)', 'timeFrame': '3 Month', 'description': 'This is the dose that the patient takes regularly to relieve pain.'}], 'secondaryOutcomes': [{'measure': 'Adverse effect', 'timeFrame': '3 Month', 'description': 'It is an unwanted effect due to the intervention given to the patient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perineal Pain', 'Cervical Cancer', 'Endometrial Cancer', 'Superior Hypogastric Plexus Block', 'Ganglion Impar Block', 'pelvic pain'], 'conditions': ['Cervical Cancer', 'Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '28613745', 'type': 'BACKGROUND', 'citation': 'Fowler JR, Maani EV, Dunton CJ, Gasalberti DP, Jack BW. Cervical Cancer. 2023 Nov 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431093/'}, {'pmid': '22905480', 'type': 'BACKGROUND', 'citation': 'Vrachnis N, Iavazzo C, Salakos N, Papamargaritis E, Boutas I, Creatsas G. Uterine tamponade balloon for the management of massive hemorrhage during cesarean section due to placenta previa/increta. Clin Exp Obstet Gynecol. 2012;39(2):255-7.'}, {'pmid': '29929349', 'type': 'BACKGROUND', 'citation': 'Yoon SY, Oh J. Neuropathic cancer pain: prevalence, pathophysiology, and management. Korean J Intern Med. 2018 Nov;33(6):1058-1069. doi: 10.3904/kjim.2018.162. Epub 2018 Jun 25.'}, {'pmid': '20539035', 'type': 'BACKGROUND', 'citation': 'Schmidt BL, Hamamoto DT, Simone DA, Wilcox GL. Mechanism of cancer pain. Mol Interv. 2010 Jun;10(3):164-78. doi: 10.1124/mi.10.3.7.'}, {'pmid': '26009665', 'type': 'BACKGROUND', 'citation': 'Bhatnagar S, Gupta M. Evidence-based Clinical Practice Guidelines for Interventional Pain Management in Cancer Pain. Indian J Palliat Care. 2015 May-Aug;21(2):137-47. doi: 10.4103/0973-1075.156466.'}, {'pmid': '29276402', 'type': 'BACKGROUND', 'citation': 'Gunduz OH, Kenis-Coskun O. Ganglion blocks as a treatment of pain: current perspectives. J Pain Res. 2017 Dec 14;10:2815-2826. doi: 10.2147/JPR.S134775. eCollection 2017.'}, {'pmid': '196561', 'type': 'BACKGROUND', 'citation': 'Khan MA, Ashrafi SH, Decker SJ. The hepatic ultrastructure of chlordene-fed pigeons. Arch Environ Contam Toxicol. 1977;5(4):385-402. doi: 10.1007/BF02220919.'}, {'pmid': '32694387', 'type': 'BACKGROUND', 'citation': 'Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. 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Pain Physician. 2020 Mar;23(2):203-208.'}, {'pmid': '29089683', 'type': 'BACKGROUND', 'citation': 'Gonnade N, Mehta N, Khera PS, Kumar D, Rajagopal R, Sharma PK. Ganglion impar block in patients with chronic coccydynia. Indian J Radiol Imaging. 2017 Jul-Sep;27(3):324-328. doi: 10.4103/ijri.IJRI_294_16.'}, {'pmid': '33776112', 'type': 'BACKGROUND', 'citation': "Bakshi SG, Rathod A, Salunkhe S. Influence of interpretation of pain scores on patients' perception of pain: A prospective study. Indian J Anaesth. 2021 Mar;65(3):216-220. doi: 10.4103/ija.IJA_130_21. Epub 2021 Mar 13."}, {'pmid': '33389199', 'type': 'BACKGROUND', 'citation': 'Phedy P, Djaja YP, Tobing SDAL, Gatam L, Librianto D, Fachrisal, Gatam AR, Hardiansyah NP. Cross-cultural adaptation and psychometric validation of the Indonesian version of the Oswestry Disability Index. Eur Spine J. 2021 Apr;30(4):1053-1062. doi: 10.1007/s00586-020-06690-3. Epub 2021 Jan 2.'}, {'pmid': '21615855', 'type': 'BACKGROUND', 'citation': 'Bhatnagar S, Khanna S, Roshni S, Goyal GN, Mishra S, Rana SP, Thulkar S. Early ultrasound-guided neurolysis for pain management in gastrointestinal and pelvic malignancies: an observational study in a tertiary care center of urban India. Pain Pract. 2012 Jan;12(1):23-32. doi: 10.1111/j.1533-2500.2011.00467.x. Epub 2011 May 26.'}]}, 'descriptionModule': {'briefSummary': 'This study compared the efficacy and safety of superior hypogastric plexus block and ganglion impar block procedures on the management of pelvic and perineal cancer pain in patients with cervical and endometrial cancer', 'detailedDescription': 'Superior hypogastric plexus block is a commonly used method for the management of pelvic and perineal pain due to cancer, this procedure uses a transdiscal approach at the level of the L5-S1 vertebrae by injecting 5 ml of 1% lidocaine + 10 ml of 96% alcohol and confirmed by C-arm.\n\nCompared with the ganglion impar block procedure using a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm. The aim of this study was to compare the efficacy and safety of the ganglion impar block procedure against the superior hypogastric plexus block which is commonly used in the management of pelvic and perineal pain due to cervical and endometrial cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unbearable cancer pain that is resistant to WHO (World Health Organization) pain ladder at least 2 weeks medication\n* The patient is tired of taking medication orally or complications of current medication (respiratory depression, nausea, vomiting, opioid-induced constipation, gastrointestinal disturbances)\n* Patients with pelvic floor pain diagnosed by a (Fellow of Interventional Pain Practice) FIPP-certified pain specialist\n* Patients with pain in the perineum diagnosed by a FIPP-certified pain specialist\n* Numerical Rating Scale \\>4\n* \\>18 years old\n* Able and willing to sign an informed consent\n\nExclusion Criteria:\n\n* Refuse to be included in the research\n* Blood clotting disorders (including taking anticoagulant drugs)\n* Local infection in the area of action\n* Loss to follow up\n\nDrop-out Criteria:\n\n* Loss to follow up\n* Intervention complications occur\n* Failed intervention'}, 'identificationModule': {'nctId': 'NCT05427058', 'briefTitle': 'Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Brawijaya'}, 'officialTitle': 'Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management: A Randomized Controlled Trial of Efficacy and Safety', 'orgStudyIdInfo': {'id': 'UB_WWN01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1: superior hypogastric plexus block group', 'description': 'Device: C-arm fluoroscopic device Drug: lidocaine + alcohol', 'interventionNames': ['Procedure: Superior Hypogastric Plexus Block']}, {'type': 'EXPERIMENTAL', 'label': 'group 2: ganglion impar block group', 'description': 'Device: C-arm fluoroscopic device Drug: lidocaine + alcohol', 'interventionNames': ['Procedure: Ganglion Impar Block']}], 'interventions': [{'name': 'Superior Hypogastric Plexus Block', 'type': 'PROCEDURE', 'description': 'this procedure uses a transdiscal approach at the level of the L5-S1 vertebrae by injecting 5 ml of 1% lidocaine + 10 ml of 96% alcohol and confirmed by C-arm.', 'armGroupLabels': ['group 1: superior hypogastric plexus block group']}, {'name': 'Ganglion Impar Block', 'type': 'PROCEDURE', 'description': 'this procedure uses a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm.', 'armGroupLabels': ['group 2: ganglion impar block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65111', 'city': 'Malang', 'state': 'East Java', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': "Fa'urinda R Prabu Nery, S1", 'role': 'CONTACT', 'email': 'neririam@gmail.com', 'phone': '+62 813-3617-2271'}, {'name': 'Ristiawan M Laksono, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Hospital Saiful Anwar Malang', 'geoPoint': {'lat': -7.9797, 'lon': 112.6304}}], 'centralContacts': [{'name': 'Ristiawan M Laksono, MD,FIPP', 'role': 'CONTACT', 'email': 'ristiawanm@ub.ac.id', 'phone': '+6281233773593'}], 'overallOfficials': [{'name': 'Ristiawan M Laksono', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brawijaya University'}, {'name': 'Andika B Effendi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Brawijaya University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Brawijaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ristiawan Muji Laksono, MD', 'investigatorAffiliation': 'University of Brawijaya'}}}}