Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT03807505
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2018-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of diaphragmatic paresis or paralysis', 'timeFrame': 'Before block placement, and 30 minutes after catheter is bolused in recovery', 'description': 'Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery'}, {'measure': 'Pain score', 'timeFrame': '48 hours', 'description': 'Pain scores for all patients will be recorded through the first 48 hours postoperatively using the Numeric Rating scale (ranging from 0 to 10, 0 is no pain and 10 is the worst imaginable pain).'}], 'secondaryOutcomes': [{'measure': 'Brachial plexus sensory exam change', 'timeFrame': 'Before block placement, and 30 minutes after catheter is bolused in recovery', 'description': 'Brachial plexus sensory exam change: dichotomous measurement (yes or no) for change in sensation over C5-C8 dermatomes'}, {'measure': 'Brachial plexus motor exam change', 'timeFrame': 'Before block placement, and 30 minutes after catheter is bolused in recovery', 'description': 'Brachial plexus motor exam change: dichotomous measurement (yes or no) for change in finger extension, finger abduction and thumb opposition to resistance'}, {'measure': 'Opioid Consumption', 'timeFrame': '48 hours', 'description': 'Opioid consumption in the recovery room and in the first 48 hours postoperatively will be recorded'}, {'measure': 'Adverse effects', 'timeFrame': '72 hours', 'description': 'Patient-reported adverse effects (dichotomous measure, yes/no): dyspnea, Horner syndrome, hoarseness, difficulty participating in physical therapy due to block'}, {'measure': 'Patient satisfaction', 'timeFrame': '72 hours', 'description': 'Patient satisfaction with the nerve block (dichotomous measure: yes/no)'}, {'measure': 'Incentive spirometry volume change', 'timeFrame': '24 hours', 'description': 'Change in incentive spirometry volume from baseline (prior to block) to recovery room, and to postoperative day 1.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Local', 'Phrenic Nerve Paralysis', 'Upper Extremity Injury', 'Shoulder Injury']}, 'referencesModule': {'references': [{'pmid': '2006740', 'type': 'BACKGROUND', 'citation': 'Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.'}, {'pmid': '18682410', 'type': 'BACKGROUND', 'citation': 'Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.'}, {'pmid': '30292068', 'type': 'BACKGROUND', 'citation': 'Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.'}, {'pmid': '29868941', 'type': 'BACKGROUND', 'citation': 'Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.'}, {'pmid': '29134518', 'type': 'BACKGROUND', 'citation': 'Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.'}, {'pmid': '35237953', 'type': 'DERIVED', 'citation': 'Sun LY, Basireddy S, Gerber LN, Lamano J, Costouros J, Cheung E, Boublik J, Horn JL, Tsui BCH. Continuous interscalene versus phrenic nerve-sparing high-thoracic erector spinae plane block for total shoulder arthroplasty: a randomized controlled trial. Can J Anaesth. 2022 May;69(5):614-623. doi: 10.1007/s12630-022-02216-1. Epub 2022 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is the evaluation of erector spinae plane (ESP) blocks as an alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total shoulder arthroplasty procedures. Currently, single shot interscalene nerve blocks are performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for total shoulder arthroplasty surgeries. Erector spinae plane blocks are commonly used as part of the anesthetic plan for other surgeries, but less so for shoulder surgeries. The investigators would like to study whether an ESP block can provide similar pain control compared to an interscalene nerve block, with less risk of upper extremity motor block and phrenic nerve block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- All adult patients (18 years and over) scheduled for rotator cuff surgery or total shoulder arthroplasty surgery requiring a nerve block as part of their anesthetic care\n\nExclusion Criteria:\n\n* concomitant life-threatening injuries and other concomitant injuries causing significant pain.\n* pregnancy,\n* any condition impairing patient's ability to consent to participation in study\n* an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder\n* infection in the vicinity of the block, and patient refusal."}, 'identificationModule': {'nctId': 'NCT03807505', 'briefTitle': 'Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery', 'orgStudyIdInfo': {'id': '48351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interscalene nerve block', 'description': 'Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot interscalene brachial plexus nerve block or an interscalene brachial plexus nerve catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.', 'interventionNames': ['Procedure: Interscalene brachial plexus nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erector Spinae Plane block', 'description': 'Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot erector spinae plane block or receive erector spinae plane catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.', 'interventionNames': ['Procedure: Erector spinae plane block']}], 'interventions': [{'name': 'Interscalene brachial plexus nerve block', 'type': 'PROCEDURE', 'description': 'An interscalene brachial plexus nerve block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.', 'armGroupLabels': ['Interscalene nerve block']}, {'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'An erector spinae plane block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.', 'armGroupLabels': ['Erector Spinae Plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Health Care (SHC)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Ban Tsui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology, Perioperative and Pain Medicine', 'investigatorFullName': 'Chi-Ho Ban Tsui', 'investigatorAffiliation': 'Stanford University'}}}}