Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT05699902
Status:
UNKNOWN
Last Update Posted:
2023-01-26
First Post:
2022-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pectoral Nerve Block During Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2022-12-11', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain', 'timeFrame': '1year', 'description': 'Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).'}], 'secondaryOutcomes': [{'measure': "Patient's quality of life", 'timeFrame': '1 year', 'description': '1. Postoperative pain score on movement Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)\n2. Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Pain after mastectomy', 'PECs block'], 'conditions': ['Breast Cancer Female', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '31382323', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Otake H, Hara E, Blanco R. How to Use Pectoral Nerve Blocks Effectively-An Evidence-Based Update. Asian J Anesthesiol. 2019 Jun 1;57(2):28-36. doi: 10.6859/aja.201906_57(2).0002.'}, {'pmid': '34195767', 'type': 'BACKGROUND', 'citation': 'Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.'}, {'pmid': '34081262', 'type': 'BACKGROUND', 'citation': 'Daniel Pereira D, Bleeker H, Malic C, Barrowman N, Shadrina A. Pectoral nerve block and acute pain management after breast reduction surgery in adolescent patients. Can J Anaesth. 2021 Oct;68(10):1574-1575. doi: 10.1007/s12630-021-02037-8. Epub 2021 Jun 3. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A prospective study', 'detailedDescription': "Breast cancer is the most common malignancy in women; surgery is still the mainstay for the treatment of breast cancer .\n\nPostoperative pain can seriously reduce the quality of patient's life, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during mastectomy, but their applications are limited by the complicated technique of the procedures and several complications.\n\nIn recent years, there has been increasing interest on a novel, less invasive technique, the pectoral nerve (PECS) block. Numerous clinical trials have focused on the analgesic potential of the pectoral nerve block in breast augmentation surgery, small breast surgery, and breast cancer surgery, and have shown positive results.\n\nSeveral prospective observational studies in recent years demonstrated that postoperative pain following breast surgery becomes chronic in up to 57% of women.\n\nOne of the most important risk factors is insufficiently treated postoperative acute pain. The current gold standard for acute postoperative pain is a preventive procedure-specific multimodal treatment including nonopioids, opioids and regional analgesia.\n\nA recently published Cochran's meta-analysis demonstrated that regional analgesia \\[e.g. paravertebral block (PVB), local infiltration\\] might even reduce the risk of chronic postsurgical pain after breast surgery. According to a recently published guidelines, pectoral nerves (PECS) blocks seem to be an effective alternative to PVB to manage effectively postsurgical pain in major breast surgery.Anatomical studies revealed a different local anaesthetic spread following injections between the pectoralis major and minor muscles (PECS I) and a combination of the latter injection with a deeper injection between the pectoralis minor and serratus anterior muscles (PECS II) but the results were not conclusive. Many trials have been published and some meta-analyses revealed a high analgesic efficacy following PECS II blocks compared with no block or PVB.\n\nHowever, one of these meta-analyses was criticised because of methodological problems (e.g. evidence assessment, missing sham block group), pain intensities not analysed separately for resting pain and pain during movement and comparisons with other established or emerging regional anaesthetic techniques (e.g. local infiltration, erector spinae block) were not performed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1- all female planed for elective breast surgery\n\nExclusion Criteria:\n\n1. Planned for bilateral axillary or bilateral reconstruction surgery.\n\n * Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.\n2. Current or past medical history of liver disease or cirrhosis with an elevated INR \\>1.4 or currently elevated transaminase levels.\n3. known contraindications to peripheral nerve block placement.\n4. Pregnant or breastfeeding.\n5. History of allergic reactions attributed to compounds of similar chemical or biologic composition\n6. Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy).'}, 'identificationModule': {'nctId': 'NCT05699902', 'acronym': 'PNB', 'briefTitle': 'Pectoral Nerve Block During Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Pectoral Nerve Block as a Part of Enhanced Recovery After Mastectomy', 'orgStudyIdInfo': {'id': 'Pectoral nerve block in breast'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PECs block group', 'description': 'Female undergone mastectomy and received pectoral nerve block', 'interventionNames': ['Procedure: PECs block during mastectomy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non PECs block group', 'description': 'Female undergone mastectomy and not received pectoral nerve block but have received conventional analgesic methods', 'interventionNames': ['Procedure: Sham block']}], 'interventions': [{'name': 'PECs block during mastectomy', 'type': 'PROCEDURE', 'otherNames': ['PECs nerve injection'], 'description': 'The patients were randomised to receive a PECS block consisting of 30 ml of levobupivacaine 0.25% after induction of anaesthesia (PECS group) or a saline mock block (control group). The patients answered a 40-item QoR questionnaire (QoR-40) before and 1 day after breast cancer surgery. MAIN OUTCOME MEASURES', 'armGroupLabels': ['PECs block group']}, {'name': 'Sham block', 'type': 'PROCEDURE', 'otherNames': ['Non PECs block'], 'description': 'Female undergone mastectomy and have received conventional analgesic methods', 'armGroupLabels': ['Non PECs block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Khaled Salah, Resident Dr', 'role': 'CONTACT', 'email': 'ksa53516@gmail.com', 'phone': '+201030026633', 'phoneExt': '+2'}, {'name': 'Mohamed Rizk, Lecturer', 'role': 'CONTACT', 'email': 'med.rizk٨٨@aun.edu.eg', 'phone': '+201061988555', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'Mostafa Alaa eldin, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'url': 'http://ksa53516@gmail.com', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'description': 'The study will be available when the targeted number of cases reached', 'accessCriteria': 'Full access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Khaled Salah Abd-Ellah', 'investigatorAffiliation': 'Assiut University'}}}}