Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-02 @ 1:13 AM
Study NCT ID:
NCT06451705
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pecs Block vs Local Infiltration in Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-blind randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Plasma Interleukin-6', 'timeFrame': '1 hour before surgery, 2 hour after surgery, 12 hour after surgery', 'description': 'in pg/dL'}, {'measure': 'Neutrophil-lymphocyte ratio', 'timeFrame': '1 hour before surgery, 2 hour after surgery, 12 hour after surgery', 'description': 'Neutrophil divided by lymphocyte'}, {'measure': 'Pain intensity (Using Numeric Rating Scale)', 'timeFrame': 'hour 0, 2, 4, 6, 12, 24', 'description': 'Scale from 0-10, lower score = better outcome'}, {'measure': 'Rescue opioid requirement', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Using fentanyl at a dose of 0.5-1 μg/kg/IV titrated as needed, in mcg (given if the patient had NRS of \\>4/10)'}], 'secondaryOutcomes': [{'measure': 'Demographic baseline data', 'timeFrame': 'baseline (before the surgery)', 'description': 'Medical record number, age, body weight (in kilogram), height (in centimeter), BMI (in kg/m2), ASA PS class, duration of surgery (in minutes)'}, {'measure': 'Time until first rescue opioid requirement', 'timeFrame': 'Within 24 hours after surgery', 'description': 'in minutes'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Nausea and vomiting were assessed using a numerical scale (0 = no nausea, 1 = mild nausea, 2 = severe nausea or vomiting once, and 3 = vomiting more than once). If the score was \\> 2, rescue antiemetics with ondansetron 0.1 mg/IV were given.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'modified radical mastectomy', 'peripheral nerve block', 'local infiltration anesthesia', 'pectoralis nerve block'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Studied the comparison between PECS II block and LIA on pain intensity, opioid requirements, RNL, and postoperative IL-6 levels in MRM patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-60 years old.\n2. Body weight (BW): 50-70 kg.\n3. Height (TB): 150-170 cm.\n4. Body mass index (BMI): 18.5-29.9 kg/m2.\n5. American Society of Anesthesiologists physical status (ASA PS) class I-II.\n6. Patients undergoing elective MRM surgery under general anesthesia.\n\nExclusion Criteria:\n\n1. Patients with contraindications to PECS II block.\n2. Patients with contraindications to LIA.\n3. Patients with coagulation disorders or receiving anticoagulant therapy.\n4. Patients with a history of chronic pain.\n5. Patients with a history of allergy to study materials.\n6. Patients with a history of previous breast surgery.\n7. Patient refuses to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06451705', 'acronym': 'PBLIM', 'briefTitle': 'Pecs Block vs Local Infiltration in Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hasanuddin University'}, 'officialTitle': 'Comparison Between Pectoral Nerve Block II and Local Anesthesia Infiltration of Isobaric Bupivacaine 0.25% 50 MG on Neutrophil-Lymphocyte Ratio, Interleukin-6 Levels, Pain Intensity, and Post-surgical Opioid Requirements in Modified Radical Mastectomy Patients', 'orgStudyIdInfo': {'id': '173/UN4.6.4.5.31/PP36/2AZ4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PECS', 'description': 'PECS II block before surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)', 'interventionNames': ['Drug: PECS II block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LIA', 'description': 'Local infiltration anesthesia after completion of surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)', 'interventionNames': ['Drug: LIA']}], 'interventions': [{'name': 'PECS II block', 'type': 'DRUG', 'description': 'Treatment group that received the PECS II block using isobaric bupivacaine 0.5% 50 mg', 'armGroupLabels': ['PECS']}, {'name': 'LIA', 'type': 'DRUG', 'description': 'Treatment group that received the local infiltration anesthesia using isobaric bupivacaine 0.5% 50 mg', 'armGroupLabels': ['LIA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90173', 'city': 'Makassar', 'state': 'South Sulawesi', 'country': 'Indonesia', 'facility': 'RSUP dr. Wahidin Sudirohusodo', 'geoPoint': {'lat': -5.14861, 'lon': 119.43194}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasanuddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jokevin Prasetyadhi', 'investigatorAffiliation': 'Hasanuddin University'}}}}