Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-03-02 @ 5:19 PM
Study NCT ID:
NCT03698006
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2018-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2018-10-02', 'studyFirstSubmitQcDate': '2018-10-03', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption (mg)', 'timeFrame': '24 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Total morphine consumption (mg)', 'timeFrame': '2 hours, 48 hours and 72 hours postoperatively'}, {'measure': 'Analgesic duration (minutes)', 'timeFrame': 'Postoperative day 0', 'description': 'Time from the block to the first analgesic request'}, {'measure': 'Pain scores (numeric rating scale, 0-10) at rest and on movement', 'timeFrame': '2 hours, 24 hours, 48 hours and 72 hours postoperatively', 'description': '0= no pain, 10=the worst pain imaginable'}, {'measure': 'Rate of postoperative nausea and vomiting', 'timeFrame': '2 hours, 24 hours, 48 hours and 72 hours postoperatively', 'description': 'Yes/No'}, {'measure': 'Rate of prurit', 'timeFrame': '2 hours, 24 hours, 48 hours and 72 hours postoperatively', 'description': 'Yes/No'}, {'measure': 'Active flexion', 'timeFrame': '24hours, 48hours and 72hours postoperatively', 'description': 'Flexion of the knee by the patient measured in degrees'}, {'measure': 'Passive flexion', 'timeFrame': '24hours, 48hours and 72hours postoperatively', 'description': 'Flexion of the knee by physiotherapist measured in degrees'}, {'measure': 'Quadriceps muscle strength (numeric scale, 1-5)', 'timeFrame': '24hours, 48hours and 72hours postoperatively', 'description': '1=no contraction, 5=normal strength'}, {'measure': 'Distance walked (meters)', 'timeFrame': '24hours, 48hours and 72hours postoperatively'}, {'measure': 'Complication of tibial nerve block', 'timeFrame': 'up to 1 week', 'description': 'Intravascular injection/hematoma/infection/Common peroneal nerve block'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'up to 14 days', 'description': 'Days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '22543069', 'type': 'BACKGROUND', 'citation': "Sinha SK, Abrams JH, Arumugam S, D'Alessio J, Freitas DG, Barnett JT, Weller RS. Femoral nerve block with selective tibial nerve block provides effective analgesia without foot drop after total knee arthroplasty: a prospective, randomized, observer-blinded study. Anesth Analg. 2012 Jul;115(1):202-6. doi: 10.1213/ANE.0b013e3182536193. Epub 2012 Apr 27."}]}, 'descriptionModule': {'briefSummary': 'Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient scheduled for a total knee arthroplasty under spinal block.\n* Patient with a weight above 40kg.\n\nExclusion Criteria:\n\n* Patient with ASA IV status.\n* Contraindication to spinal block, or peripheral nerve blocks.\n* Neurological deficit of the lower limb.\n* Patient with renal dysfunction.\n* Patient with chronic pain, opioid consumption or alcohol consumption.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT03698006', 'briefTitle': 'Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia', 'orgStudyIdInfo': {'id': 'CER 2018-01080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tibial nerve block', 'description': 'Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.', 'interventionNames': ['Drug: Ropivacaine 0.5% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local infiltration analgesia', 'description': 'Adductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery.', 'interventionNames': ['Drug: Ropivacaine 0.2% Injectable Solution']}], 'interventions': [{'name': 'Ropivacaine 0.5% Injectable Solution', 'type': 'DRUG', 'description': 'Tibial nerve block with 10ml of Ropivacaine 0.5%', 'armGroupLabels': ['Tibial nerve block']}, {'name': 'Ropivacaine 0.2% Injectable Solution', 'type': 'DRUG', 'description': 'Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule', 'armGroupLabels': ['Local infiltration analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1004', 'city': 'Lausanne', 'state': 'English', 'country': 'Switzerland', 'facility': 'Eric Albrecht', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program director of regional anaesthesia', 'investigatorFullName': 'Eric Albrecht', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}