Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-02 @ 7:10 AM
Study NCT ID:
NCT07067892
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2025-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Ultrasonography-Guided Serratus Posterior Superior Intercostal Plane Block in Thoracic Postherpetic Neuralgia: A Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-06', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale -11 (NRS-11)', 'timeFrame': '3 months', 'description': "It is an 11-point scale used to describe pain. It is based solely on the patient's ability to perform activities of daily living and can be used for adults and children ages 10 and older."}], 'secondaryOutcomes': [{'measure': 'Douleur Neuropathique en 4 Questions(DN4)', 'timeFrame': '3 months', 'description': 'The DN4 questionnaire is a validated clinical screening instrument designed to detect the presence of neuropathic pain. It was developed by the French Neuropathic Pain Group to address diagnostic challenges and the lack of consensus regarding the identification of neuropathic pain. Owing to its clarity and ease of use, the instrument has been widely adopted in clinical practice and research since 2005.\n\nThe questionnaire comprises four sections and ten individual items. Seven items pertaining to pain quality-including sensory descriptors-are obtained through a structured patient interview and reflect the subjective characteristics of the pain experience. The remaining three items are derived from the clinical examination, during which the clinician evaluates for decreased sensitivity to light touch or pinprick (hypoesthesia), as well as the presence of pain provoked or exacerbated by gentle brushing (allodynia).'}, {'measure': 'Short Form- 12', 'timeFrame': '3 months', 'description': 'The SF-12 consists of 12 items grouped into eight subscales: physical functioning (2 items), role physical (2 items), bodily pain (1 item), general health (1 item), vitality (1 item), social functioning (1 item), role emotional (2 items), and mental health (2 items). Items pertaining to physical and emotional role limitations are dichotomous (yes/no), whereas the remaining items are rated on Likert-type scales ranging from three to six response options.\n\nThe Physical Component Summary (PCS-12) score is derived from the general health, physical functioning, role physical, and bodily pain subscales. The Mental Component Summary (MCS-12) score is calculated from the social functioning, role emotional, mental health, and vitality subscales. Both PCS-12 and MCS-12 scores range from 0 to 100, with higher scores indicating better health status. The SF-12 is a validated and psychometrically robust instrument.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postherpetic Neuralgia ( PHN ), Ultrasound Guided, Block', 'Ultrasound Guided Injection']}, 'descriptionModule': {'briefSummary': "Postherpetic neuralgia (PHN) is a chronic pain syndrome that can be resistant to treatment, leading to physical and social disability, psychological disturbances, and potentially persisting for years . The varicella-zoster virus remains latent in the sensory neurons of individuals who have previously contracted varicella (chickenpox). Reactivation of the latent virus results in herpes zoster (HZ). In most patients, HZ initially presents with dermatomal pain, and within a few days, characteristic dermatomal vesicular eruptions typically develop. These skin lesions usually heal within 2-4 weeks; however, pain may persist even after the resolution of the rash .\n\nThe pathogenesis of PHN involves increased sensitization of central neurons, decreased function of inhibitory neuronal pathways, inflammation and nerve injury within the peripheral nervous system, and abnormal signal transmission following such damage. PHN represents the most common complication of HZ. It occurs in approximately 9-19% of all patients with HZ. The incidence of PHN increases with advancing age: it affects approximately 2% of individuals younger than 50 years, about 20% of those older than 50 years, and nearly 35% of those older than 80 years . Various treatment modalities, including pharmacologic agents and interventional procedures, are available for the management of PHN-related pain. This study primarily aims to evaluate the change in pain in PHN patients who underwent SPSIPB using the NRS-11. The secondary aim was to evaluate the effect of SPSIPB on neuropathic pain characteristics using the DN-4 scale and to investigate its effects on patients' quality of life using SF-12 scale.", 'detailedDescription': "After obtaining approval from the relevant ethics committee (University of Health Sciences, Istanbul Kanuni Sultan Suleyman Training and Research Hospital, KAEK/2025.05.139), patients over 18 years of age who underwent a single-session ultrasound (US)-guided serratus posterior superior intercostal plane block (SPSIPB) in the thoracic region (T1-T10 dermatomes) due to PHN between June 2023 and February 2025 were retrospectively evaluated. SPSIPB was performed in patients whose complaints persisted despite existing medical treatments. The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients enrolled in the study, which was carried out at the pain clinic of a tertiary care hospital. This retrospective, single-center cohort study was designed.\n\nA total of 34 patients who met the inclusion criteria were included in the study .\n\nPatients were excluded if they had cervical disc herniation; a history of trauma or surgery involving the neck, shoulder, or back; malignancy; kyphoscoliosis; a history of inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis); congenital spinal anomalies; neck pain accompanied by neurological deficits; pregnancy; mental or psychotic disorders; hematologic diseases causing bleeding or coagulation disorders; use of antiplatelet or anticoagulant drugs or medications predisposing to bleeding; severe systemic infections such as sepsis; local infections at the planned intervention site; known allergies to any of the drugs to be used; or a history of invasive procedures for PHN in the thoracic region within the past 3 months.\n\nData Collection and Assessment Scales The following data were collected: Age, gender, body mass index (BMI), affected side in PHN, duration of PHN and affected dermatome, history of HZ vaccination (live/recombinant), data regarding immunosuppression (Human Immunodeficiency Virus, active cancer, high-dose steroids), PHN family history, level of procedure performed, complications, Numeric Rating Scale-11 (NRS-11), Neuropathic Pain Questionnaire (DN4), Short Form-12 (SF-12) quality of life index subscores and average daily tramadol (mg/day) consumption before and 1 and 3 months after the procedure were recorded.\n\nMedication Management Patients' gabapentinoids and antidepressants (amiltriptyline, duloxetine, etc.) used for PHN were continued. Tramadol doses were either increased or decreased for pain control after SPSIPB. Total daily average tramadol consumption was recorded before, at the end of the first and third months after the procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years of age who underwent a single-session ultrasound (US )guided serratus posterior superior intercostal plane block (SPSIPB) in the thoracic region (T1-T10 dermatomes) for PHN between June 2023 and February 2025 were evaluated. SPSIPB was performed in patients whose complaints persisted despite existing medical treatments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients over 18 years of age\n\n\\- who underwent a single-session ultrasound (US)-guided serratus posterior superior intercostal plane block (SPSIPB) in the thoracic region (T1-T10 dermatomes) for PHN between June 2023 and February 2025 were evaluated. -SPSIPB was performed in patients whose complaints persisted despite existing medical treatments.\n\nExclusion Criteria:Patients were excluded if they had cervical disc herniation -a history of trauma or surgery involving the neck, shoulder, or back; -malignancy- kyphoscoliosis; a history of inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis)\n\n* congenital anomalies of the spine; neck pain accompanied by neurological deficits\n* pregnancy\n* mental or psychotic disorders\n* hematologic diseases causing bleeding or coagulation disorders\n* use of antiplatelet or anticoagulant drugs or other medications predisposing to bleeding\n* severe systemic infections such as sepsis\n* local infection at the planned intervention site\n* known allergy to any of the drugs to be used; or a history of invasive procedures for PHN in the thoracic region within the past three months.'}, 'identificationModule': {'nctId': 'NCT07067892', 'acronym': 'pain', 'briefTitle': 'Effectiveness of Ultrasonography-Guided Serratus Posterior Superior Intercostal Plane Block in Thoracic Postherpetic Neuralgia: A Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Effectiveness of Ultrasonography-Guided Serratus Posterior Superior Intercostal Plane Block in Thoracic Postherpetic Neuralgia: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'postherpetic neuralgia, block'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Effectiveness of Ultrasonography-Guided Serratus Posterior Superior Intercostal Plane Block in Thora'}]}, 'contactsLocationsModule': {'locations': [{'zip': '(507) 277-4773', 'city': 'Küçükçekmece', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İKanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 40.99104, 'lon': 28.77123}}], 'overallOfficials': [{'name': 'halil ibrahim altun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kanuni Sultan Süleyman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pain specialist', 'investigatorFullName': 'Halil Ibrahim Altun', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}