Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:36 AM
Study NCT ID:
NCT07446868
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided SPSIP Versus ESPB for Postoperative Pain After Modified Radical Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be blinded to group allocation. Postoperative pain assessment and data collection will be performed by investigators who are unaware of group assignment. The anesthesiologist performing the block cannot be blinded due to the nature of the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block or ultrasound-guided erector spinae plane block (ESPB) prior to modified radical mastectomy. Both groups will receive standardized general anesthesia and multimodal analgesia. Outcomes will be compared between groups during the first 24 postoperative hours.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total 24-Hour Postoperative Morphine Consumption', 'timeFrame': 'First 24 hours postoperatively', 'description': 'Total cumulative dose of intravenous morphine (in milligrams) administered during the first 24 hours after surgery as rescue analgesia. Morphine (3 mg IV) will be administered when the Visual Analogue Scale (VAS) score is ≥ 4. The total amount consumed over 24 hours will be recorded and compared between the two study groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector Spinae Plane Block', 'Modified Radical Mastectomy', 'Serratus Posterior Superior Intercostal Plane Block'], 'conditions': ['Breast Cancer', 'Postoperative Pain', 'Acute Post-surgical Pain']}, 'referencesModule': {'references': [{'pmid': '36883093', 'type': 'RESULT', 'citation': 'Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.'}, {'pmid': '30207593', 'type': 'RESULT', 'citation': 'Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer is the most common cancer affecting women worldwide. Modified radical mastectomy is one of the main surgical treatments for breast cancer. However, this surgery is often associated with significant postoperative pain, which may delay recovery and increase the need for opioid medications such as morphine.\n\nRegional anesthesia techniques are increasingly used to improve pain control after breast surgery and reduce opioid consumption. The erector spinae plane block (ESPB) is a well-established ultrasound-guided technique that provides effective chest wall analgesia. The serratus posterior superior intercostal plane (SPSIP) block is a newer ultrasound-guided technique that targets intercostal nerves and may provide effective postoperative pain relief.\n\nThe purpose of this randomized clinical trial is to compare the effectiveness of SPSIP block versus ESPB block in controlling pain after modified radical mastectomy. The primary outcome will be total morphine consumption during the first 24 hours after surgery. Secondary outcomes include pain scores, time to first request for rescue analgesia, hemodynamic stability, recovery profile, patient satisfaction, and postoperative side effects such as nausea and vomiting.\n\nThis study aims to determine whether the newer SPSIP block provides comparable or superior pain control to ESPB, with the goal of improving postoperative recovery and reducing opioid requirements in breast cancer patients.', 'detailedDescription': 'Breast cancer represents a major global health burden and remains one of the leading causes of cancer-related mortality among women. Modified radical mastectomy (MRM) is frequently performed as part of surgical management. Despite advances in perioperative care, postoperative pain following MRM remains significant due to extensive tissue dissection involving skin, muscles, and intercostal nerves.\n\nInadequate postoperative analgesia may result in delayed mobilization, increased opioid consumption, higher incidence of opioid-related adverse effects, prolonged hospital stay, and potential development of chronic post-mastectomy pain syndrome.\n\nUltrasound-guided fascial plane blocks have gained popularity as part of multimodal analgesia strategies in breast surgery. The erector spinae plane block (ESPB) involves injection of local anesthetic deep to the erector spinae muscle at the thoracic level, allowing spread to dorsal and ventral rami of spinal nerves. ESPB has demonstrated effectiveness in reducing postoperative pain scores and opioid consumption after breast surgery.\n\nThe serratus posterior superior intercostal plane (SPSIP) block is a recently described regional anesthesia technique. It involves ultrasound-guided injection of local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles, targeting the intercostal nerves. Preliminary reports suggest that SPSIP may provide effective thoracic analgesia with a favorable safety profile.\n\nThis prospective randomized clinical trial will include 50 female breast cancer patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University. Patients will be randomly assigned into two equal groups:\n\nGroup SPSIP: Ultrasound-guided serratus posterior superior intercostal plane block.\n\nGroup ESPB: Ultrasound-guided erector spinae plane block.\n\nBoth blocks will be performed preoperatively under ultrasound guidance using 20 mL of 0.25% bupivacaine. All patients will receive standardized general anesthesia and multimodal analgesia.\n\nThe primary outcome measure is total morphine consumption during the first 24 hours postoperatively.\n\nSecondary outcomes include:\n\nVisual Analog Scale (VAS) pain scores at rest and during movement at predefined time intervals (1, 3, 6, 12, 18, and 24 hours)\n\nTime to first request for rescue analgesia\n\nHemodynamic parameters intraoperatively and postoperatively\n\nRecovery time\n\nPatient satisfaction\n\nIncidence of adverse effects such as nausea and vomiting\n\nThe study hypothesis is that SPSIP block provides postoperative analgesia comparable or superior to ESPB in patients undergoing modified radical mastectomy.\n\nThe results of this study may contribute to optimizing regional anesthesia strategies for breast cancer surgery and support evidence-based, opioid-sparing perioperative pain management.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale patients diagnosed with breast cancer\n\nScheduled for modified radical mastectomy (MRM)\n\nAmerican Society of Anesthesiologists (ASA) physical status II or III\n\nAge 18-65 years\n\nBody mass index (BMI) \\> 20 kg/m² and \\< 35 kg/m²\n\nAbility to understand the study protocol and provide written informed consent\n\nExclusion Criteria:\n\nPatient refusal to participate\n\nASA physical status IV or higher\n\nBMI ≤ 20 kg/m² or ≥ 35 kg/m²\n\nKnown hypersensitivity or contraindication to local anesthetics, opioids, or study medications\n\nHistory of chronic pain or regular opioid use\n\nSignificant psychiatric disorders affecting pain assessment\n\nContraindications to regional anesthesia (e.g., infection at injection site, coagulopathy, pre-existing peripheral neuropathy)\n\nSevere respiratory, cardiac, hepatic, or renal disease'}, 'identificationModule': {'nctId': 'NCT07446868', 'acronym': 'SPSIP-ESPB', 'briefTitle': 'Ultrasound-Guided SPSIP Versus ESPB for Postoperative Pain After Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Pain Management After Modified Radical Mastectomy: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SPSIP-ESPB-MRM-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPSIP Block Group', 'description': 'Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. All participants will receive standardized general anesthesia and multimodal postoperative analgesia.', 'interventionNames': ['Procedure: Serratus Posterior Superior Intercostal Plane Block']}, {'type': 'EXPERIMENTAL', 'label': 'ESPB Block Group', 'description': 'Participants will receive an ultrasound-guided erector spinae plane block (ESPB) before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be injected deep to the erector spinae muscle at the T4-T5 transverse process level. All participants will receive standardized general anesthesia and multimodal postoperative analgesia.', 'interventionNames': ['Procedure: Erector Spinae Plane Block']}], 'interventions': [{'name': 'Serratus Posterior Superior Intercostal Plane Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided serratus posterior superior intercostal plane block performed preoperatively. A 22G block needle is advanced in-plane under ultrasound guidance to the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. After negative aspiration, 20 mL of 0.25% bupivacaine is injected. The block is performed 30-45 minutes before surgery.', 'armGroupLabels': ['SPSIP Block Group']}, {'name': 'Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided erector spinae plane block performed preoperatively. A 22G needle is inserted in-plane to contact the transverse process at the T4-T5 level. After confirmation of correct placement and negative aspiration, 20 mL of 0.25% bupivacaine is injected deep to the erector spinae muscle. The block is performed 30-45 minutes before surgery.', 'armGroupLabels': ['ESPB Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'sayed M abed, MD', 'role': 'CONTACT', 'email': 'sydabed2020@outlook.com', 'phone': '01226806532'}, {'name': 'sara F ali, MSc', 'role': 'CONTACT', 'email': 'Sarafarghaly1234@gmail.com', 'phone': '+20 111588521'}], 'facility': 'National Cancer Institute - Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sayed M Abed, MD', 'role': 'CONTACT', 'email': 'sayed.abed@nci.cu.edu.eg', 'phone': '+20 122 680 6532'}, {'name': 'Sara F Ali, MSc', 'role': 'CONTACT', 'email': 'Sarafarghaly1234@gmail.com', 'phone': '+20 111588521'}], 'overallOfficials': [{'name': 'Sayed M Abed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Anesthesia and Pain Management, National Cancer Institute -- Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality. Although all data will be anonymized, sharing individual-level data outside the research team is not permitted under the current Institutional Review Board (IRB) approval. Aggregated results will be available through publication and may be provided upon reasonable request to the corresponding author, in accordance with institutional regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sayed Mahmoud Abed', 'investigatorAffiliation': 'Cairo University'}}}}