Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-25 @ 11:06 PM
Study NCT ID:
NCT05427292
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2022-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sufficient surgical anesthesia', 'timeFrame': 'up to 30 minutes', 'description': "After confirming the sensory block in the surgical area with the post-procedure pinpirick test, successful completion of the surgical procedure 'without the need for deep sedoanalgesia' will be considered 'sufficient surgical anesthesia'."}], 'secondaryOutcomes': [{'measure': 'Pain scores on the Numeric Rating Scale (NRS)', 'timeFrame': 'up to 24 hours', 'description': 'Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").'}, {'measure': 'Quality of recovery 15 scale', 'timeFrame': 'up to 24 hours', 'description': 'Postoperative Quality of Recovery 15 in Turkish scale'}, {'measure': 'analgesic consumption', 'timeFrame': 'up to 24 hours', 'description': 'In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected'}, {'measure': 'modified Wilson Sedation Scale', 'timeFrame': 'up to 2 hours', 'description': '1. Oriente, eyes may be closed, but says his name, answers where he is\n2. Sleepy, eyes may be closed, can be warned when called by name\n3. Can be stimulated by mild physical stimulation (earlobe)\n4. Cannot be stimulated by mild physical stimulation'}, {'measure': 'quality of anesthesia', 'timeFrame': 'up to 2 hours', 'description': 'Are you satisfied with the anesthesia? Would you like to have surgery with the same technique again? Would you recommend it to others?\n\n1. Extremely satisfied,\n2. Satisfied,\n3. Neither satisfied nor dissatisfied,\n4. Not satisfied,\n5. It will be calculated by responding as highly dissatisfied.'}, {'measure': 'scaling working conditions', 'timeFrame': 'up to 2 hours', 'description': 'Working conditions scaling\n\nIndistinguishable from general anesthesia A little challenging/enough It will be determined by choosing one of the overly challenging/inadequate options.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional anesthesia', 'interfascial plane block', 'Main anesthetic method'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '29327341', 'type': 'RESULT', 'citation': 'Pawa A, Wight J, Onwochei DN, Vargulescu R, Reed I, Chrisman L, Pushpanathan E, Kothari A, El-Boghdadly K. Combined thoracic paravertebral and pectoral nerve blocks for breast surgery under sedation: a prospective observational case series. Anaesthesia. 2018 Apr;73(4):438-443. doi: 10.1111/anae.14213. Epub 2018 Jan 12.'}, {'pmid': '22939099', 'type': 'RESULT', 'citation': 'Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this study is to determine the success of combined serratus anterior and PECS-2 block as the main anesthetic method in breast cancer surgery and also to investigate the patient acceptability of this combination and its relationship with surgeon satisfaction.', 'detailedDescription': 'Breast conserving surgery or mastectomy is applied in the surgical treatment of breast cancer. Axillary interventions range from sentinal lymph node biopsy to lymph node dissection. Clinically significant acute pain develops following breast surgery in 35% of patients.\n\nToday, regional anesthesia is widely used as an opioid-sparing strategy in the treatment of acute postoperative pain. New fascial plane blocks have been developed as alternative or complementary techniques for chest wall analgesia, including pectoral nerve blocks (PECS1-2) and serratus plane block.\n\nIn order to reduce the risk of perioperative morbidity and mortality and to meet the patient demand, the demand for awake surgery is increasing in institutions.\n\nTherefore, a prospective observational case series was conducted to explain the efficacy, patient acceptability, and surgeon satisfaction of combined serratus anterior and PECS-2 block as the main anesthetic method for breast cancer surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients aged 18-80 years with breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18-80 and ASA I-III who will undergo unilateral breast cancer surgery will be included in the study.\n\nExclusion Criteria:\n\n* Patients with previous breast surgery other than excisional biopsy,\n* coagulopathy,\n* bleeding disease,\n* local infection at the injection site,\n* history of local anesthetic allergy,\n* psychiatric disease (depression, mania, schizophrenia or antipsychotic drug use),\n* history of opioid use for more than 4 weeks\n* Patients with body mass index (BMI) \\>40kg/m2 and\n* chest deformity (pectus excavatum and pectus carinatum) will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT05427292', 'briefTitle': 'Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Samsun University'}, 'officialTitle': 'Feasibilty of Serratus Anterior and Pectoral Nerve Blocks (PECS II) Combination as Main Anesthetic Method in Breast Cancer Surgery Patients', 'orgStudyIdInfo': {'id': 'SamsunU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'serratus anterior block and PECs II block combination', 'type': 'OTHER', 'description': 'The pre-surgery block will be applied. Sensorial block will be evaluated at the surgical incision site with the pinpirick test at 30 minutes after the block, and if the block is successful, surgery will begin.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55100', 'city': 'Samsun', 'state': 'Ilkadım', 'country': 'Turkey (Türkiye)', 'facility': 'Samsun University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': '55040', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Samsun University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'gamze MD ertaş, specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsun University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gamze Ertas', 'investigatorAffiliation': 'Samsun University'}}}}