Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
Study NCT ID:
NCT06718868
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2024-12-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the effect of PECSII block on the development of chronic pain in patients undergoing oncological breast surgery', 'timeFrame': '3 months', 'description': 'Female patients over 18 years of age, non-pregnant, cooperative, and who agreed to participate in the study, who underwent oncological breast surgery, were contacted by phone in the 3rd month post-operation and evaluated for the development of chronic pain using the PAIN Detect pain scale.Only patients who received routine intravenous analgesia and patients who received PECSII block in addition to routine intravenous analgesia were included in the study. The patients were divided into two groups. The development of chronic pain in the block group was compared with the patients in the non-block group. The surgical technique applied to the patients was recorded from the patient files. The relationship between surgical technique and pain occurrence was evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oncological breast surgery, PECS II Block, chronic pain, acute pain'], 'conditions': ['Breast Carcinoma', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to evaluate the effect of Pectoral Nerve Block II (PECSII) on the development of pain in the acute and chronic periods in female patients over the age of 18 who underwent oncological breast surgery. The main questions it aims to answer are:\n\nIs PECSII blockade applied to patients undergoing oncological breast surgery effective on acute pain scores compared to the non-blockade group? Is there a difference between the group with block and the group without block in terms of the development of chronic pain in the evaluation made at the 3rd month after surgery? The analgesia method applied to the patients will be recorded in the patient files and acute and chronic pain scores will be evaluated. Chronic pain score evaluation will be made by telephone survey.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '128 patients who met the inclusion criteria were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will be operated under general anesthesia\n* ASA score I-II-III patients\n* Non-pregnant patients\n* Patients who agreed to participate in the study\n\nExclusion Criteria:\n\n* Patients with coagulopathy\n* Patients who underwent bilateral mastectomy\n* Patients with chest wall anomalies\n* Patients with neuropathic pain before surgery\n* Patients who did not agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT06718868', 'briefTitle': 'Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery', 'orgStudyIdInfo': {'id': 'E-48670771-514.99-232052317'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients in Group 1 were defined as those who received PECSII Block in addition to intravenous analgesia.'}, {'label': 'Group 2', 'description': 'Patients in Group 2 were defined as patients who received intravenous analgesia only.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Serap Karacalar, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Prof. Dr. Cemil Tascioglu Education and Research Hospital'}, {'name': 'İrem Erkan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. Dr. Cemil Tascioglu Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Irem Erkan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor', 'investigatorFullName': 'Irem Erkan', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}