Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-04 @ 9:00 PM
Study NCT ID:
NCT03738735
Status:
UNKNOWN
Last Update Posted:
2018-11-13
First Post:
2018-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'daily for 14 days post-operatively', 'description': 'pain rated on scale of 1-10'}, {'measure': 'Morphine equivalent', 'timeFrame': 'weekly for first 2 weeks post-operatively', 'description': 'opiod comsumption'}], 'secondaryOutcomes': [{'measure': 'American Shoulder Elbow Surgeons standardized shoulder assessment form', 'timeFrame': '3 months and 6 months', 'description': 'shoulder function'}, {'measure': 'Passive range of motion', 'timeFrame': '6 weeks, 3 months, 6 months', 'description': 'passive range of motion'}, {'measure': 'Active range of motion', 'timeFrame': '3 months, 6 months', 'description': 'Active range of motion'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroscopic Shoulder Surgery', 'Rotator Cuff Tear']}, 'referencesModule': {'references': [{'pmid': '28318850', 'type': 'BACKGROUND', 'citation': 'Capito NM, Cook JL, Yahuaca B, Capito MD, Sherman SL, Smith MJ. Safety and efficacy of hyperosmolar irrigation solution in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 May;26(5):745-751. doi: 10.1016/j.jse.2017.02.021. Epub 2017 Mar 18.'}, {'pmid': '25725966', 'type': 'BACKGROUND', 'citation': 'Capito NM, Smith MJ, Stoker AM, Werner N, Cook JL. Hyperosmolar irrigation compared with a standard solution in a canine shoulder arthroscopy model. J Shoulder Elbow Surg. 2015 Aug;24(8):1243-8. doi: 10.1016/j.jse.2014.12.027. Epub 2015 Feb 25.'}]}, 'descriptionModule': {'briefSummary': "The goal of this project is to perform a randomized, double-blinded study investigating postoperative pain after arthroscopic rotator cuff using hyperosmolar saline as opposed to lactated ringer's solution (normal osmolarity) as arthroscopy irrigation solutions. Hyperosmolar saline is an irrigation solution with a higher concentration of solutes that will be used intraoperatively to washout the surgical field. It will be used in place of lactated ringer's solution, which has an osmolarity comparable to that of normal saline. This study will help determine whether or not postoperative pain from rotator cuff repair can be mitigated by altering the osmolarity of the intraoperative irrigation solution. This knowledge is significant because the postoperative pain can be intense, so much so that patients may depend on narcotics for pain relief. Consequently, this study may provide benefit by helping to find new ways to minimize the need for narcotics. The main hypothesis of this is study is that hyperosmolar saline will reduce perceived pain and narcotic use in the postoperative period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\> 18 years of age\n\nPatients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears\n\nExclusion Criteria:\n\nPatients younger than 18 years of age\n\nPatients who are pregnant, mentally disabled, or imprisoned\n\nPatients not receiving inter-scalene nerve block (catheters excluded)\n\nPatients undergoing labral repair, capsular release, or distal clavicle excision\n\nPatients with irreparable rotator cuff tears\n\nPatients receiving any repair augmentation or graft\n\nPatients with a known hypersensitivity to sodium lacta'}, 'identificationModule': {'nctId': 'NCT03738735', 'briefTitle': 'Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Prospective, Double Blinded, Randomized Control Trial on Effect of Hyperosmlar Saline in Reducing Postoperative Pain Following Arthroscopic Rotator Cuff Repair', 'orgStudyIdInfo': {'id': '2018Davis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery."}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery.', 'interventionNames': ['Drug: Hypertonic saline']}], 'interventions': [{'name': 'Hypertonic saline', 'type': 'DRUG', 'description': "For the intervention group, the surgical staff will add 120 mL of 23.4% saline to the 3L bags of lactated Ringer's solution, and this new solution will be used for arthroscopic irrigation purposes throughout the rotator cuff repair surgery.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liam Kane, BS', 'role': 'CONTACT', 'email': 'Liam.Kane@rothmanortho.com', 'phone': '2673393593'}, {'name': 'Thema Nicholson', 'role': 'CONTACT', 'email': 'thema.nicholson@rothmanortho.com', 'phone': '2673393615'}], 'overallOfficials': [{'name': 'Ryan Cox, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}, {'name': 'Daniel Davis, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rothman Orthopaedics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}