Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 5:43 AM
Study NCT ID:
NCT03942133
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2019-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-29', 'studyFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative sulfentanil consumption at 24 hours after surgery', 'timeFrame': '24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'the strength of quadriceps femoris', 'timeFrame': '0,2,4,8,24,48 hours postoperatively', 'description': 'Quadriceps strength was assessed on a 0-5 scale as per the Medical Research Council Scale quadriceps motor strength(0 = no voluntary contraction possible, 1 = muscle flicker, but no movement of limb, 2 = active movement only with gravity eliminated, 3 = movement against gravity but without resistance, 4 = movement possible against some resistance and 5 = normal motor strength against resistance)'}, {'measure': 'The pain scores at rest determined by the numeric rating scale (NRS, 0-10)', 'timeFrame': 'at 0,2,4,8,24,48 hours postoperatively', 'description': '11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).'}, {'measure': 'The pain scores on adduction of the keen determined by the numeric rating scale (NRS, 0-10)', 'timeFrame': 'at 0,2,4,8,24,48 hours postoperatively', 'description': '11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).'}, {'measure': 'incidence of postoperative nausea and vomiting (PONV)', 'timeFrame': 'within 48 hours after surgery'}, {'measure': 'Patient satisfaction with anesthesia', 'timeFrame': 'within 5th day after surgery', 'description': 'Patient satisfaction with anesthesia was assessed using a 5-point scale (5, very satisfied; 4, satisfied; 3, neither satisfied nor dissatisfied; 2, dissatisfied; 1, very dissatisfied)'}, {'measure': 'complications', 'timeFrame': 'within 3days after surgery', 'description': 'Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.'}, {'measure': 'cumulative sulfentanil consumption at other time points after surgery', 'timeFrame': '2,4,8,48 hours postoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adductor canal block'], 'conditions': ['Total Knee Arthroplasty', 'Analgesia', 'Nerve Block']}, 'referencesModule': {'references': [{'pmid': '33036554', 'type': 'DERIVED', 'citation': 'Fei Y, Cui X, Chen S, Peng H, Feng B, Qian W, Lin J, Weng X, Huang Y. Continuous block at the proximal end of the adductor canal provides better analgesia compared to that at the middle of the canal after total knee arthroplasty: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2020 Oct 9;20(1):260. doi: 10.1186/s12871-020-01165-w.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the tow technique of continues adductor canal block for total knee replacement surgery. Half participants will receive catheterization at the entrance of the adductor canal, while the other half will receive catheterization at the middle point of the adductor canal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years\n* Knee-arthroscopy\n* Written consent\n* ASA I-III\n* BMI 19-35\n\nExclusion Criteria:\n\n* Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).\n* coagulopathy or on anticoagulant medication\n* Allergic reactions toward drugs used in the trial\n* History of substance abuse\n* Infection at injection site\n* Can not be mobilised to 5 meters of walk pre-surgery'}, 'identificationModule': {'nctId': 'NCT03942133', 'briefTitle': 'Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Block at the Entrance and Middle of the Canal', 'orgStudyIdInfo': {'id': 'CXL1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'entrance placement of adductor canal catheter', 'interventionNames': ['Procedure: ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal']}, {'type': 'EXPERIMENTAL', 'label': 'middle point placement of adductor canal catheter', 'interventionNames': ['Procedure: ultrasound-guided long-axis placement of catheter at the middle of the adductor canal']}], 'interventions': [{'name': 'ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal', 'type': 'PROCEDURE', 'description': 'Ultrasound probe is placed at the entrance of the adductor canal in short axis ，insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the entrance of the canal', 'armGroupLabels': ['entrance placement of adductor canal catheter']}, {'name': 'ultrasound-guided long-axis placement of catheter at the middle of the adductor canal', 'type': 'PROCEDURE', 'description': 'Ultrasound probe is placed at the middle of the adductor canal in long axis with the caphelad end of the probe aligned with the entrance of the canal. insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the middle of the canal', 'armGroupLabels': ['middle point placement of adductor canal catheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Cui Xulei', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}