Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 7:48 AM
Study NCT ID:
NCT04443894
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2020-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'PATIENT OUTCOME ASSESSOR'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-21', 'studyFirstSubmitDate': '2020-06-21', 'studyFirstSubmitQcDate': '2020-06-21', 'lastUpdatePostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intensity of acute postoperative pain', 'timeFrame': '24 hours', 'description': 'intensity of acute postoperative pain, numeric rating scale 0-10'}], 'secondaryOutcomes': [{'measure': 'intensity of chronic pain', 'timeFrame': '3 months', 'description': 'intensity of chronic pain with numeric rating scale 0-10'}, {'measure': 'Prevalence of chronic neuropathic pain', 'timeFrame': '3 months', 'description': 'Prevalence of chronic pain at the site of surgery, measured with the LANSS questionnaire'}, {'measure': 'Prevalence of chronic neuropathic pain', 'timeFrame': '3 months', 'description': 'Prevalence of chronic pain at the site of surgery, measured with YES./NO'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'mastectomy', 'PECS'], 'conditions': ['Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration']}, 'descriptionModule': {'briefSummary': "Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Patients in our study are divided in two groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.", 'detailedDescription': 'Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group. Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. Patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local aneshetic is administered in both groups after the induction of general anesthesia and before incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'only women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years of age\n* ASA physical status I-III\n* elective partial mastectomy\n\nExclusion Criteria:\n\n* refusal of patient participation or inability to participate to the study\n\n * known allergic reaction to drugs included in the study design\n * contraindiations of performance of peripheral regional anesthesia\n * diabetes melitus or known neurological disorder\n * chronic pain disorders under therapy with opioids or other analgesic drugs for chronic pain\n * all male patients\n * all patients not speaking the Greek language'}, 'identificationModule': {'nctId': 'NCT04443894', 'briefTitle': 'Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?', 'orgStudyIdInfo': {'id': 'BreastPecs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PECS block', 'interventionNames': ['Other: PECS block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'local infiltration', 'interventionNames': ['Other: local infiltration']}], 'interventions': [{'name': 'PECS block', 'type': 'OTHER', 'description': 'PECS block is performed at the side of surgery (II) before incision with ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).', 'armGroupLabels': ['PECS block']}, {'name': 'local infiltration', 'type': 'OTHER', 'description': 'local infiltration of the surgical wound before incision with πwith ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).', 'armGroupLabels': ['local infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Chrysanthi Batistaki, MD, PhD', 'role': 'CONTACT', 'email': 'chrysabatistaki@yahoo.gr', 'phone': '0030 210 5832371'}], 'facility': '2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Eleftheria Soulioti, MD,PhD', 'role': 'CONTACT', 'email': 'eleftheriasoulioti@ymail.com', 'phone': '00306946745366'}, {'name': 'Chrysanthi Batistaki, MD,PhD', 'role': 'CONTACT', 'email': 'chrysabatistaki@yahoo.gr', 'phone': '00302105832371'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anaesthesiology', 'investigatorFullName': 'Chrysanthi Batistaki', 'investigatorAffiliation': 'Attikon Hospital'}}}}