Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-01-03 @ 9:37 AM
Study NCT ID:
NCT02033603
Status:
UNKNOWN
Last Update Posted:
2015-01-01
First Post:
2014-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adductor Canal Versus Femoral Nerve Block for Analgesia Post Total Knee Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-31', 'studyFirstSubmitDate': '2014-01-09', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2015-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'first 24 hours'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '1, 6, 12, 24, 48'}, {'measure': 'Morphine consumption', 'timeFrame': '48 hours'}, {'measure': 'Side effects of opioids- sedation, nausea and vomiting', 'timeFrame': '48 hours'}, {'measure': 'Quadriceps strength, ability to mobilise', 'timeFrame': '24, 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total knee arthroplasty', 'Total knee replacement', 'Femoral Nerve Block', 'Adductor Canal Block'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the knee which is increasingly performed as the population ages. It is a painful surgery and one of the methods to reduce post-operative pain is performing a regional anaesthesia technique. The current practice is to perform a femoral nerve block (FNB) which blocks the nerves supplying the knee joint and the thigh muscles (quadriceps). This provides effective analgesia. However, it also results in weakness of the quadriceps and may result in falls post-operatively.\n\nAdductor canal block (ACB) is a new, alternative regional anaesthesia technique which is hypothesised to provide as effective analgesia, with less quadriceps weakness compared to FNB, hence potentially reducing the risk of falls post-operatively.\n\nInvestigators aim to study if the analgesia provided by ACB is as good as FNB while preserving quadriceps strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 45-85\n* American Society of Anaesthesiologists physical status 1-3\n* BMI 18-35 kg/m2\n\nExclusion Criteria:\n\n* inability to give consent, communicate, cooperate\n* Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids\n* Patients with allergy to local anaesthetics or any drugs included in the study\n* Patients with lower limb surgery in the preceding year\n* Patients with pre-existing neurological deficits\n* Patients who are unsuitable for general anaesthetics (eg difficult airway)'}, 'identificationModule': {'nctId': 'NCT02033603', 'briefTitle': 'Adductor Canal Versus Femoral Nerve Block for Analgesia Post Total Knee Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Femoral Nerve Block for Analgesia Post Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2013/ 921/ D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral Nerve Block', 'description': 'Femoral Nerve block performed with 0.5% Ropivacaine 30mls (150mg)', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor Canal block', 'description': 'Adductor Canal block performed with 0.5% Ropivacaine 30mls (150mg)', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['naropin'], 'description': '30mls of 0.5% ropivacaine', 'armGroupLabels': ['Adductor Canal block', 'Femoral Nerve Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'CTRU', 'role': 'CONTACT', 'phone': '67888833'}], 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'CTRU CGH', 'role': 'CONTACT', 'phone': '67888833'}], 'overallOfficials': [{'name': 'Yean Chin Lim, MBBS, MMed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}