Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-04 @ 3:51 PM
Study NCT ID:
NCT03154658
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2017-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Serratus Anterior Plane Block in Patients Undergoing Mastectomy
Sponsor:
Organization:
Raw JSON
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'anthony.machi@utsouthwestern.edu', 'phone': '2146486400', 'title': 'Anthony Machi M.D.', 'organization': 'University of Texas Southwestern'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Sub-serratus Regional Block', 'description': 'A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.\n\nRopivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 14, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Supra-serratus Regional Block', 'description': 'A regional block using of ropivacaine 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administered to the injection site deep to the serratus anterior muscle.\n\nRopivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.'}, {'id': 'OG001', 'title': 'Supra-serratus Regional Block', 'description': 'A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.\n\nRopivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post block', 'description': 'Measures the change in pain scores 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used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.\n\nRopivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.62', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post block', 'description': 'Pain satisfaction with regards to post-operative pain management within the first 24 hours post op on a 1-5 Likert scale of (1 poor, 2 fair, 3 good, 4 very good, 5 excellent).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Nausea/Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sub-serratus Regional Block', 'description': 'A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.\n\nRopivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.'}, {'id': 'OG001', 'title': 'Supra-serratus Regional Block', 'description': 'A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.\n\nRopivacaine 0.35%: The serratus plane block is used to supplement the pain management 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'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep Duration Night of Postoperative Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sub-serratus Regional Block', 'description': 'A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.\n\nRopivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.'}, {'id': 'OG001', 'title': 'Supra-serratus Regional Block', 'description': 'A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.\n\nRopivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.'}], 'classes': [{'categories': [{'measurements': [{'value': '315', 'spread': '114', 'groupId': 'OG000'}, {'value': '276', 'spread': '80.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post block', 'description': 'Measures the total duration of sleep in minutes that subjects report sleeping on the night after surgery between postoperative days 0 and 1', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Block Performance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sub-serratus Regional Block', 'description': 'A regional block using of ropivacaine 0.35% (30 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{'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.7', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.9', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '30.2', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '29.0', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intraoperative length', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '321.6', 'spread': '110.1', 'groupId': 'BG000'}, {'value': '323.0', 'spread': '114.7', 'groupId': 'BG001'}, {'value': '322.3', 'spread': '111.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tissue expander placement', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Axillary node dissection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Women over the age of 18 who underwent a mastectomy, either unilateral or bilateral, with or without tissue expander placement, and with or without axillary node dissection were recruited.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-24', 'size': 181761, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-14T11:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized interventional prospective model to investigate effect of block placement in two treatment arms. Opioid consumption in the first 24 hours after the operation will be main outcome variable.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2017-05-03', 'resultsFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2017-05-12', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-04', 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': '24 hours post block', 'description': 'Measures number of milligrams morphine equivalents each subject receives'}], 'secondaryOutcomes': [{'measure': 'Maximum Post-operative Pain Score', 'timeFrame': '24 hours post block', 'description': 'Measures the change in pain scores on a 0-10 Numeric Rating Scale where 0 is no pain and 10 is the maximum pain.'}, {'measure': 'Patient Satisfaction Scale', 'timeFrame': '24 hours post block', 'description': 'Pain satisfaction with regards to post-operative pain management within the first 24 hours post op on a 1-5 Likert scale of (1 poor, 2 fair, 3 good, 4 very good, 5 excellent).'}, {'measure': 'Number of Participants With Nausea/Vomiting', 'timeFrame': '24 hours post block', 'description': 'Measures the type and frequency of anti-emetics subjects receive'}, {'measure': 'Length of Stay', 'timeFrame': '10 Days', 'description': 'Measures total number of days subject is hospitalized, including day of surgery'}, {'measure': 'Sleep Duration Night of Postoperative Day 0', 'timeFrame': '24 hours post block', 'description': 'Measures the total duration of sleep in minutes that subjects report sleeping on the night after surgery between postoperative days 0 and 1'}, {'measure': 'Block Performance Time', 'timeFrame': 'Time from procedure needle insertion until needle removal, estimate less than 5 minutes', 'description': 'Measures total time for block to take effect'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Post-operative']}, 'referencesModule': {'references': [{'pmid': '34364099', 'type': 'DERIVED', 'citation': 'Edwards JT, Langridge XT, Cheng GS, McBroom MM, Minhajuddin A, Machi AT. Superficial vs. deep serratus anterior plane block for analgesia in patients undergoing mastectomy: A randomized prospective trial. J Clin Anesth. 2021 Dec;75:110470. doi: 10.1016/j.jclinane.2021.110470. Epub 2021 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, interventional prospective study. Patients (n=66) undergoing mastectomies with or without tissue expander will be randomized to receive a supra-serratus or sub-serratus regional plane block prior to surgery. The main effect to be measured is total opioid consumption 24 hours after the operation. Secondary endpoints include measuring a change between pre-and post-operative pain scores, patient satisfaction of pain control during first 24 hours after the operation, presence of postoperative nausea and vomiting, duration of sleep on first postoperative night, and block performance time and length of stay, between the two treatment arms.', 'detailedDescription': 'Subjects will be randomized to one of two groups: the supra-serratus anterior plane block (depositing local anesthetic superficial to the serratus anterior muscle) or the sub-serratus anterior plane block (depositing local anesthetic deep to the serratus anterior muscle). Randomization will be performed using a computer generated randomization program. The results of the randomization will be revealed to the physician performing the block just prior to its performance. The site of the block will be marked and a safety timeout will be performed with the block nurse, regional anesthesiologist, and patient present and participating.\n\nOnce the above is completed, patients will receive a pre-operative ultrasound-guided single-injection serratus anterior plane block using either the supra-serratus or sub-serratus techniques according to their randomization. The block nurse will record the time when the timeout is performed, the "needle insertion" time when the block needle enters the skin, and the "block complete" time when the needle exits the skin. If the block is bilateral, the block nurse will record the time when the timeout is performed, then will record two sets of "needle in" times and "needle out" times, one for each side. In the case of a bilateral block, the same method of serratus anterior plane block will be utilized for both sides.\n\nAfter the block, the patient will proceed to surgery. The operating room anesthesia team will be notified that the patient received a serratus anterior plane block. An appropriate multimodal general anesthetic will be employed at the operating room anesthesiologist\'s discretion. Upon completion of the surgery and emergence from general anesthesia, the patient will be seen by study personnel in the Post Anesthesia Care Unit and pain will be evaluated using a 0-10 Likert scale (0=no pain, 10= worst imaginable pain) about 1 hour post-operatively. Pain will be evaluated again by study personnel using the same scale on post-operative day #1, about 24 hours after initial block placement. If the patient is discharged home prior to the post-operative day #1 assessment, a phone interview will be performed 24 hours following the block to evaluate the post-operative day #1 scores and monitor for adverse events. Additional pain scores will be documented in the electronic medical record by nursing staff per protocol, and will be collected by study personnel.\n\nDuring the intraoperative and post-operative period, the patient will continue to receive an appropriate multimodal analgesic regimen as necessary to adequately control the pain. No pain control method will be withheld from the patient as a result of participating in the study.\n\nPatient satisfaction scores will also be used as a measure to evaluate quality of perioperative pain management. These scores will be assessed on post-operative day #1 on a scale of 1 to 5 (Poor=1, Fair=2, Good=3 Very good=4, Excellent=5).\n\nDuring follow-up on post-operative day #1, the patients will also be asked for an estimate on duration and quality of sleep to help assess their general comfort level during their first post-operative night.\n\nDuring the routine post-operative visit, an assessment of post-operative nausea and vomiting will be made by asking the patient directly. Chart review looking for post-operative antiemetic usage will also be evaluated to assess the presence of post-operative nausea and vomiting.\n\nThe decision as to whether or not to perform a serratus anterior plane block (SAPB) will be made independent from the introduction of the patient to the study. Therefore, the patient\'s choice to receive a SAPB will not be affected by the introduction of the study or their desire to participate in a clinical investigation. A multimodal intraoperative anesthetic technique will be employed for all patients, and post-operative pain control will be managed by the patient\'s primary surgical team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients 18 years or older\n2. Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.\n\nExclusion Criteria:\n\n1. Any known sensory deficit of the anterolateral chest wall.\n2. Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block\n3. Pregnancy\n4. American Society of Anesthesiology classification greater than 3\n5. Allergy to amide local anesthetic medications\n6. Chronic pain conditions\n7. Preoperative opioid use greater than 20 oral morphine equivalents per day\n8. Any coagulation abnormality which would be a contraindication for block placement\n9. Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL\n10. Body mass index \\>50\n11. Incarceration\n12. Inability to understand study procedures including inability to understand the English language\n13. Inability to provide adequate informed consent\n14. Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03154658', 'briefTitle': 'Serratus Anterior Plane Block in Patients Undergoing Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Serratus Anterior Plane Block: Sub-Serratus vs Supra-Serratus Plane Block for Pain Control in Patients Undergoing Mastectomy', 'orgStudyIdInfo': {'id': 'STU 122016-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sub-serratus regional block', 'description': 'A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.', 'interventionNames': ['Drug: Ropivacaine 0.35%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supra-serratus regional block', 'description': 'A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.', 'interventionNames': ['Drug: Ropivacaine 0.35%']}], 'interventions': [{'name': 'Ropivacaine 0.35%', 'type': 'DRUG', 'otherNames': ['Ropivacaine'], 'description': 'The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.', 'armGroupLabels': ['Sub-serratus regional block', 'Supra-serratus regional block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Centers', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Anthony Machi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anthony Machi', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}