Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT07051434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep During Recovery: Effect of Preoperative Regional Block on Postoperative Sleep Quality in Mastectomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Sleep Quality Measured by RCSQ', 'timeFrame': 'Postoperative Day 1 (the morning after surgery)', 'description': 'Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on the first morning after surgery. The total score ranges from 0 (poor sleep) to 100 (excellent sleep). Comparison will be made between patients receiving general anesthesia alone and those receiving general anesthesia combined with regional block.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Quality', 'Postoperative Recovery', 'Anesthesia Techniques']}, 'referencesModule': {'references': [{'pmid': '36652140', 'type': 'RESULT', 'citation': 'Yang RZ, Li YZ, Liang M, Yu JJ, Chen ML, Qiu JJ, Lin SZ, Wu XD, Zeng K. Stellate Ganglion Block Improves Postoperative Sleep Quality and Analgesia in Patients with Breast Cancer: A Randomized Controlled Trial. Pain Ther. 2023 Apr;12(2):491-503. doi: 10.1007/s40122-022-00473-y. Epub 2023 Jan 18.'}, {'type': 'RESULT', 'citation': 'Wang H, et al. Regional Block Anesthesia in Breast Surgery: What Do We Know So Far? Open Journal of Anesthesiology. 2024;14:185-195.'}, {'pmid': '38242803', 'type': 'RESULT', 'citation': 'Ni Eochagain A, Carolan S, Buggy DJ. Regional anaesthesia truncal blocks for acute postoperative pain and recovery: a narrative review. Br J Anaesth. 2024 May;132(5):1133-1145. doi: 10.1016/j.bja.2023.12.020. Epub 2024 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study investigates the impact of preoperative regional anesthesia on postoperative sleep quality in patients undergoing mastectomy. Sleep quality will be assessed using two validated tools: the Richards-Campbell Sleep Questionnaire (RCSQ) for all participants, and the Pittsburgh Sleep Quality Index (PSQI) in a subgroup. The study also examines the relationship between sleep quality and postoperative pain, patient satisfaction, and psychological status measured by the Hospital Anxiety and Depression Scale (HADS). Patients will be grouped based on anesthesia technique-general anesthesia alone or general anesthesia combined with regional block-and sleep outcomes will be compared. The study aims to provide evidence on how anesthetic technique and psychological factors affect recovery and sleep quality after breast cancer surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult female patients (≥18 years old) scheduled for elective mastectomy surgery at a single academic hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Undergoing elective mastectomy surgery\n* ASA physical status I to III\n* Willing and able to provide written informed consent\n* Expected to remain hospitalized for at least 24 hours postoperatively\n\nExclusion Criteria:\n\n* History of major psychiatric or neurological disorders\n* Regular use of antidepressants, anxiolytics, or hypnotics\n* Difficult airway management during anesthesia (e.g., intubation or ventilation complications)\n* Reoperation within the first 24 hours after surgery\n* Inability to complete questionnaires due to deep sedation or visual/auditory impairment'}, 'identificationModule': {'nctId': 'NCT07051434', 'briefTitle': 'Sleep During Recovery: Effect of Preoperative Regional Block on Postoperative Sleep Quality in Mastectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'Sleep During Recovery: Does Preoperative Regional Block Affect Postoperative Sleep Quality in Mastectomy Patients? A Prospective Evaluation Using Two Validated Sleep Quality Scales', 'orgStudyIdInfo': {'id': 'mastektomi rcsq'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Anesthesia Only (GA)', 'description': 'Patients undergoing mastectomy with general anesthesia alone.', 'interventionNames': ['Other: Regional Analgesic Block']}, {'label': 'General Anesthesia + Regional Block (GA+RB)', 'description': 'Patients receiving both general anesthesia and regional analgesic block.', 'interventionNames': ['Other: Regional Analgesic Block']}], 'interventions': [{'name': 'Regional Analgesic Block', 'type': 'OTHER', 'description': 'Preoperative regional analgesic block performed as part of routine clinical care in selected patients undergoing mastectomy (e.g., PECS block, paravertebral block, or other truncal blocks).', 'armGroupLabels': ['General Anesthesia + Regional Block (GA+RB)', 'General Anesthesia Only (GA)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ilke dolgun', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '+905555485632'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. prof', 'investigatorFullName': 'İlke Dolgun', 'investigatorAffiliation': 'Haseki Training and Research Hospital'}}}}