Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:08 AM
Study NCT ID:
NCT07434232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "n online randomization program (http://www.randomizer.org) will be used to generate a random list and each patient's code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:Patients and outcome assessors will be blinded to the study groups."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to two groups:\n\nGroup I (Control group): patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes Block with a total volume of 30 mL local anesthetic; 15 ml per block (13.5 ml Bupivacaine 0.25% + 1.5 ml normal saline for each block).\n\nGroup II (Magnesium group).: where patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes block with a total of 30 ml local anesthetic volume; 15 ml per block (13.5ml bupivacaine 0.25% + 1.5 ml MgSo4 10% (100 mg/ml))'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intravenous opioid consumption', 'timeFrame': '24 hours postoperatively', 'description': 'total intravenous opioid consumption during the first 24 hours'}], 'secondaryOutcomes': [{'measure': 'pain intensity postoperatively at rest and during pain-provoking movements', 'timeFrame': '24 hours postoperatively', 'description': 'postoperative pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by Visual analogue scale where 0= no pain, 10= worst imaginable pain'}, {'measure': 'First request of analgesia.', 'timeFrame': '24 hours postoperatively', 'description': 'first request of opioid analgesic'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Modified Radical Mastectomy']}, 'descriptionModule': {'briefSummary': 'Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.\n\nStudy Endpoints Primary Endpoints: Total intravenous opioid consumption during the first 24 hours following surgery. Secondary Endpoints: Postoperative analgesia, 24 hours after surgery, assessed using the Visual Analog Scale (VAS) and time to first analgesic request.', 'detailedDescription': 'Modified radical mastectomy, a common surgical intervention for breast cancer therapy, and is often associated with extensive postoperative pain. Effective regional anesthesia techniques are important modalities to manage this pain and reduce total opioid consumption in the early postoperative phase. A few interfacial nerve block methods (for example, pectoral nerve blocks I and II and erector spinae plane block) are also utilized in some other procedures to reduce the postoperative pain. However, these methods require particular patient positioning.\n\nA new, minimally-invasive technique called pecto-intercostal fascial plane block (PIFB) was firstly used by De la Torre in patients who had undergone breast surgery. The Pecto-Intercostal Fascial Block (PIFB) and the Serratus Anterior Plane Block (SAPB) have appeared as promising techniques for providing pain relief in breast surgeries. PIFB targets the anterior cutaneous branches of the intercostal nerves, while SAPB focuses on the lateral cutaneous branches, each offering distinct anatomical coverage. Some specific benefits have been reported when using PIFB such as less invasiveness, proximity to the incision line, and postoperative administration with no specific patient positioning.\n\nRecent studies have examined the efficacy of adding adjuvants to local anesthetics. Magnesium sulfate, known for its NMDA receptor antagonism and calcium channel blocking properties, has been investigated for its potency to prolong pain relief and improve analgesic control when used as an adjuvant in peripheral blocks. Evaluating the efficacy of magnesium sulfate in these fascial plane blocks may lead to the establishment of an improved standard of care in postoperative pain management.\n\nWhile both PIFB and SAPB are considered safe and relatively easy to perform using ultrasound, comparative data regarding their efficacy, especially with magnesium sulfate as an adjuvant, remains limited. The outcomes of this study may help define a more effective and standardized analgesic approach for patients undergoing modified radical mastectomy. Furthermore, minimizing systemic opioid requirements is especially gaining interest considering current efforts to reduce opioid-related side effects and dependence in surgical patients.\n\nHere, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.\n\nStudy Endpoints'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 30 to 75 years diagnosed with non-metastatic breast cancer and scheduled for modified radical mastectomy.\n* ASA, I-III and NYHA, I-II.\n* Written informed consent.\n\nExclusion Criteria:\n\n* ASA physical status \\>III and NYHA \\>II,\n* body mass index \\>40 kg/m2,\n* pregnant women,\n* Patients with organ failure or coagulation disorders.\n* Allergy to local anesthetics or magnesium sulfate\n* Contraindications as local infection\n* History of chronic pain or opioid use .\n* Unwilling to participate in the study'}, 'identificationModule': {'nctId': 'NCT07434232', 'acronym': 'Mastectomy', 'briefTitle': 'Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'South Egypt Cancer Institute'}, 'officialTitle': 'Efficacy of Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy: A Prospective, Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '18-2026-810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': '(Control group):', 'description': 'patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes Block with a total volume of 30 mL local anesthetic; 15 ml per block (13.5 ml Bupivacaine 0.25% + 1.5 ml normal saline for each block).', 'interventionNames': ['Procedure: combined Pecto-Intercostal- Serratus anterior fascial planes Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(Magnesium group).:', 'description': 'where patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes block with a total of 30 ml local anesthetic volume; 15 ml per block (13.5ml bupivacaine 0.25% + 1.5 ml MgSo4 10% (100 mg/ml))', 'interventionNames': ['Procedure: combined Pecto-Intercostal- Serratus anterior fascial planes Block']}], 'interventions': [{'name': 'combined Pecto-Intercostal- Serratus anterior fascial planes Block', 'type': 'PROCEDURE', 'otherNames': ['Ultrasound guided PIFB - SAPB approach'], 'description': 'PIFB will be performed using a high-frequency linear ultrasound probe. probe should be inserted 2 cm laterally from the sternum and parallel to it. The Pecto-Intercostal Fascial plane is located between the pectoralis major muscle and the external intercostal muscle, or the costal cartilage. A 22 G 80 mm needle will be inserted under the pectoralis major and above the external intercostal muscle using the in-plane approach. Additionally, a test bolus of saline (2 mL) will be given.\n\nFor SAPB approach, patients will be positioned to the supine, and the injection sites are sterilized. The ipsilateral arm will be abducted at 90°. A high-frequency linear USG probe will be placed on the mid-axillary line in the axilla. Using an in-plane technique, a 100-mm block needle will be advanced caudo-cranially between the serratus anterior muscle and the fifth rib. After negative aspiration 1-2 mL of saline will be injected as a test dose.', 'armGroupLabels': ['(Control group):', '(Magnesium group).:']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mohamed fa abd elhamed, lecture', 'role': 'CONTACT', 'email': 'm.farghaly.na@gmail.com', 'phone': '01015249890', 'phoneExt': '02'}, {'name': 'bahaa ga saad, lecturer', 'role': 'CONTACT', 'phone': '01003644592', 'phoneExt': '02'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Egypt Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assiut University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia', 'investigatorFullName': 'Mohammed Farghaly Abd El hamid Ahmed', 'investigatorAffiliation': 'South Egypt Cancer Institute'}}}}