Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02896959
Status:
UNKNOWN
Last Update Posted:
2016-09-12
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain - VAS scale', 'timeFrame': 'Two years'}]}, 'conditionsModule': {'conditions': ['Shoulder Arthroscopy']}, 'descriptionModule': {'briefSummary': 'Postoperative surgical pain has been extensively study with regard to anaesthesia pain modalities, however little is published with regards to various arthroscopic shoulder surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive water retention from the arthroscopic pump could causes excessive tissue pressure and swelling resulting in post operative pain. Unfortunately we could not find any literature in the English language regarding varying pressure pump settings on post operative pain control. For that reason we would like to assess how variable pump pressure effect tissue pressure over pre set time points, and how this may relate to post operative pain control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients attending St. Joseph's hospital\n* Shoulder pathology amenable to arthroscopic surgery\n* Medically suitable for surgical management\n* Able to consent for surgery.\n\nExclusion Criteria:\n\n* Unable to consent\n* Active infection\n* Active malignancy\n* Drug or alcohol misuse\n* Work related injury\n* Lack of permanent home residence\n* Previous surgery to affected shoulder\n* Medical contraindiction to surgery\n* Pregnant women"}, 'identificationModule': {'nctId': 'NCT02896959', 'briefTitle': 'How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.', 'orgStudyIdInfo': {'id': '106756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '25mmHg pressure', 'description': 'Pump pressure of 25mmHg during rotator cuff repair', 'interventionNames': ['Procedure: Arthroscopic rotator cuff repair']}, {'type': 'EXPERIMENTAL', 'label': '45mmHg pressure', 'description': 'Pump pressure of 45mmHg during rotator cuff repair', 'interventionNames': ['Procedure: Arthroscopic rotator cuff repair']}, {'type': 'EXPERIMENTAL', 'label': '65mmHg pressure', 'description': 'Pump pressure of 65mmHg during rotator cuff repair', 'interventionNames': ['Procedure: Arthroscopic rotator cuff repair']}], 'interventions': [{'name': 'Arthroscopic rotator cuff repair', 'type': 'PROCEDURE', 'armGroupLabels': ['25mmHg pressure', '45mmHg pressure', '65mmHg pressure']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}