Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT01019005
Status:
UNKNOWN
Last Update Posted:
2009-11-25
First Post:
2009-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Relief After Forefoot Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057785', 'term': 'Catheters'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-24', 'studyFirstSubmitDate': '2009-11-24', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': '2,8,12,24,48 hr'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['post-operative analgesia', 'opioid', 'catheter', 'tibial nerve block'], 'conditions': ['Orthopedic Surgery']}, 'descriptionModule': {'briefSummary': 'The aim to test whether continues local anaesthetic infusion via tibial catheter or wound catheter will improve pain relief following forefoot surgery\n\nIn this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older (ASA I \\& II)\n* Able to give written consent\n* Patients having elective forefoot surgery with a planned ankle block.\n* Expected postoperative pain to be at least moderate in severity the day following surgery\n\nExclusion Criteria:\n\n* Refusal\n* Inability to communicate\n* History of alcohol or opioid abuse (also chronic opioid user)\n* Mental or medical conditions which may affect quantifying pain scores (VAS)'}, 'identificationModule': {'nctId': 'NCT01019005', 'briefTitle': 'Pain Relief After Forefoot Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham University Hospitals NHS Trust'}, 'officialTitle': 'Pain Relief After Forefoot Surgery: Tibial Perineural Catheter vs. Wound Catheter Infusion', 'orgStudyIdInfo': {'id': 'QMC-1975-HJ'}, 'secondaryIdInfos': [{'id': 'QMC-1975-NB', 'type': 'OTHER', 'domain': 'QMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tibial', 'interventionNames': ['Device: Catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Wound', 'interventionNames': ['Device: Catheter']}, {'type': 'NO_INTERVENTION', 'label': 'Sham', 'interventionNames': ['Device: Catheter']}], 'interventions': [{'name': 'Catheter', 'type': 'DEVICE', 'description': 'Catheter inserted into either perineural tibial nerve or wound', 'armGroupLabels': ['Sham', 'Tibial', 'Wound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nottingham University Hospitals NHS Trust', 'oldOrganization': "Queens' Medical Centre"}}}}