Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02946294
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2016-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-12', 'studyFirstSubmitDate': '2016-10-23', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fentanyl consumption', 'timeFrame': 'Intraoperative'}, {'measure': 'Total morphine consumption', 'timeFrame': 'The first 24 hours postoperative'}, {'measure': 'Visual analogue scale score at rest and during shoulder movement', 'timeFrame': 'The first 24 hours postoperative'}], 'secondaryOutcomes': [{'measure': 'Mean arterial blood pressure', 'timeFrame': 'Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative', 'description': 'Hemodynamics'}, {'measure': 'Heart rate', 'timeFrame': 'Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative', 'description': 'Hemodynamics'}, {'measure': 'Time to first requirement of rescue analgesia', 'timeFrame': 'The first 24 hours postoperative'}, {'measure': 'Sedation score', 'timeFrame': 'Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative', 'description': 'as a side effect of morphine'}, {'measure': 'Respiratory rate', 'timeFrame': 'Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative', 'description': 'respiratory depression defined as respiratory rate \\<12 breaths per minute'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'The first 24 hours postoperative', 'description': 'as a side effect of morphine'}, {'measure': 'Patient satisfaction with postoperative analgesia', 'timeFrame': 'One week after surgery', 'description': 'using numerical rating scale from 0 to 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '27687427', 'type': 'BACKGROUND', 'citation': 'Hards M, Harada A, Neville I, Harwell S, Babar M, Ravalia A, Davies G. The effect of serratus plane block performed under direct vision on postoperative pain in breast surgery. J Clin Anesth. 2016 Nov;34:427-31. doi: 10.1016/j.jclinane.2016.05.029. Epub 2016 Jun 16.'}, {'pmid': '27587333', 'type': 'BACKGROUND', 'citation': 'Zocca JA, Chen GH, Puttanniah VG, Hung JC, Gulati A. Ultrasound-Guided Serratus Plane Block for Treatment of Postmastectomy Pain Syndromes in Breast Cancer Patients: A Case Series. Pain Pract. 2017 Jan;17(1):141-146. doi: 10.1111/papr.12482. Epub 2016 Sep 2.'}, {'pmid': '27440171', 'type': 'BACKGROUND', 'citation': 'Mayes J, Davison E, Panahi P, Patten D, Eljelani F, Womack J, Varma M. An anatomical evaluation of the serratus anterior plane block. Anaesthesia. 2016 Sep;71(9):1064-9. doi: 10.1111/anae.13549. Epub 2016 Jul 20.'}, {'pmid': '27413485', 'type': 'BACKGROUND', 'citation': 'Okmen K, Okmen BM, Uysal S. Serratus Anterior Plane (SAP) Block Used for Thoracotomy Analgesia: A Case Report. Korean J Pain. 2016 Jul;29(3):189-92. doi: 10.3344/kjp.2016.29.3.189. Epub 2016 Jul 1.'}, {'pmid': '27051373', 'type': 'BACKGROUND', 'citation': 'Daga V, Narayanan MK, Dedhia JD, Gaur P, Crick H, Gaur A. Cadaveric feasibility study on the use of ultrasound contrast to assess spread of injectate in the serratus anterior muscle plane. Saudi J Anaesth. 2016 Apr-Jun;10(2):198-201. doi: 10.4103/1658-354X.168825.'}, {'pmid': '26934607', 'type': 'BACKGROUND', 'citation': 'Khemka R, Chakraborty A, Ahmed R, Datta T, Agarwal S. Ultrasound-Guided Serratus Anterior Plane Block in Breast Reconstruction Surgery. A A Case Rep. 2016 May 1;6(9):280-2. doi: 10.1213/XAA.0000000000000297.'}, {'pmid': '26603109', 'type': 'BACKGROUND', 'citation': 'Bhoi D, Pushparajan HK, Talawar P, Kumar A, Baidya DK. Serratus anterior plane block for breast surgery in a morbidly obese patient. J Clin Anesth. 2016 Sep;33:500-1. doi: 10.1016/j.jclinane.2015.09.004. Epub 2015 Oct 23. No abstract available.'}, {'pmid': '26437549', 'type': 'BACKGROUND', 'citation': 'Ohgoshi Y, Yokozuka M, Terajima K. [Serratus-Intercostal Plane Block for Brest Surgery]. Masui. 2015 Jun;64(6):610-4. Japanese.'}, {'pmid': '26000690', 'type': 'BACKGROUND', 'citation': 'Madabushi R, Tewari S, Gautam SK, Agarwal A, Agarwal A. Serratus anterior plane block: a new analgesic technique for post-thoracotomy pain. Pain Physician. 2015 May-Jun;18(3):E421-4.'}, {'pmid': '25247916', 'type': 'BACKGROUND', 'citation': 'Kunhabdulla NP, Agarwal A, Gaur A, Gautam SK, Gupta R, Agarwal A. Serratus anterior plane block for multiple rib fractures. Pain Physician. 2014 Sep-Oct;17(5):E651-3. No abstract available.'}, {'pmid': '25039953', 'type': 'BACKGROUND', 'citation': 'Eid M. Other potential uses of serratus anterior plane block. Anaesthesia. 2014 Aug;69(8):933-4. doi: 10.1111/anae.12778. No abstract available.'}, {'pmid': '27097516', 'type': 'BACKGROUND', 'citation': 'Kikuchi M, Takaki S, Nomura T, Goto T. [Difference in the Spread of Injectate between Ultrasound Guided Pectoral Nerve Block I and II. A Cadaver Study]. Masui. 2016 Mar;65(3):314-7. Japanese.'}, {'pmid': '25583191', 'type': 'BACKGROUND', 'citation': 'Tan YR, Quek KH. Tackling the axillary blind spot with PECS II. Anaesthesia. 2015 Feb;70(2):230-1. doi: 10.1111/anae.13005. No abstract available.'}, {'pmid': '25376971', 'type': 'BACKGROUND', 'citation': 'Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.'}, {'pmid': '25302976', 'type': 'BACKGROUND', 'citation': 'Purcell N, Wu D. Novel use of the PECS II block for upper limb fistula surgery. Anaesthesia. 2014 Nov;69(11):1294. doi: 10.1111/anae.12876. No abstract available.'}, {'pmid': '22939099', 'type': 'BACKGROUND', '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.'}, {'pmid': '32765052', 'type': 'DERIVED', 'citation': 'Bakeer AH, Kamel KM, Abdelgalil AS, Ghoneim AA, Abouel Soud AH, Hassan ME. Modified Pectoral Nerve Block versus Serratus Block for Analgesia Following Modified Radical Mastectomy: A Randomized Controlled Trial. J Pain Res. 2020 Jul 14;13:1769-1775. doi: 10.2147/JPR.S252539. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the analgesic profile of modified pectoral nerves block and serratus plane block in patients undergoing mastectomy.', 'detailedDescription': 'This study includes three groups. The first group will receive ultrasound-guided modified pectoral nerves block prior to induction of general anesthesia. The second one will receive ultrasound-guided serratus plane block prior to induction of general anesthesia. The third one will not receive any block preoperatively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation).\n\nExclusion Criteria:\n\n* Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index\\> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT02946294', 'briefTitle': 'Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery', 'orgStudyIdInfo': {'id': 'MD2010014055.3'}, 'secondaryIdInfos': [{'id': 'IRB00004025', 'type': 'OTHER', 'domain': 'Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'modified pectoral nerves block', 'description': 'Modified pectoral nerves block with general anesthesia. Using the ultrasound, 10 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis major and minor muscles. And another 20 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis minor and the serratus anterior muscles.', 'interventionNames': ['Drug: Bupivacaine 0.25% with epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'serratus plane block', 'description': 'Serratus plane block with general anesthesia. Using the ultrasound, 0.4 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the serratus anterior muscle and the underlying ribs.', 'interventionNames': ['Drug: Bupivacaine 0.25% with epinephrine']}], 'interventions': [{'name': 'Bupivacaine 0.25% with epinephrine', 'type': 'DRUG', 'otherNames': ['Markyrene'], 'armGroupLabels': ['modified pectoral nerves block']}, {'name': 'Bupivacaine 0.25% with epinephrine', 'type': 'DRUG', 'otherNames': ['Markyrene'], 'armGroupLabels': ['serratus plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'state': 'Misr Al Qadimah', 'country': 'Egypt', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ayman A Ghoneim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Cancer Institute, Cairo University'}, {'name': 'Ahmad H Aboul Soud, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Institute, Cairo University'}, {'name': 'Khaled M Salem, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Cairo University'}, {'name': 'Mohamed E Hassan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Cairo University'}, {'name': 'Ahmad H Mohamed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesia and Pain Relief', 'investigatorFullName': 'Khaled Mostafa Kamel', 'investigatorAffiliation': 'Cairo University'}}}}