Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05532618
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2022-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Medication is prepared by study personell not otherwise involved in the study according to a computer generated randomization plan. This plan will be available for analyses after the study. Primary investigator is able to retreive the allocation prematurely if indicated (emergency).'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-09', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain level', 'timeFrame': 'Within first 48 hours after surgery', 'description': 'Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine'}], 'secondaryOutcomes': [{'measure': 'Opiate use', 'timeFrame': 'Within first 48 hours after surgery', 'description': 'postoperative use of opiates (Morphine equivalent dose (mg))'}, {'measure': 'Nausea', 'timeFrame': 'Within first 48 hours after surgery', 'description': 'Postoperative nausea (yes/no)'}, {'measure': 'Block result', 'timeFrame': 'within first 24 hours after surgery', 'description': "If there's any loss of motor function (no quadriceps paresis, partial quadriceps paresis, complete quadriceps paresis.) using bromage score"}, {'measure': 'Patient satisfaction', 'timeFrame': '48 hours after surgery', 'description': 'Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adductor canal block'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'referencesModule': {'references': [{'pmid': '23788068', 'type': 'BACKGROUND', 'citation': 'Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.'}, {'pmid': '31980156', 'type': 'BACKGROUND', 'citation': 'Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery', 'detailedDescription': 'Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.\n\nBefore surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).\n\nFollowing surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Undergoing anterior cruciate ligament surgery under general anesthesia\n* ASA I-III\n\nExclusion Criteria:\n\n* Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics,\n* Neuromuscular disorders'}, 'identificationModule': {'nctId': 'NCT05532618', 'acronym': 'DUAL', 'briefTitle': 'Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NL 81489.100.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levobupivacaine', 'description': 'Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound', 'interventionNames': ['Procedure: Adductor canal block', 'Drug: Levobupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound', 'interventionNames': ['Procedure: Adductor canal block', 'Drug: Placebo']}], 'interventions': [{'name': 'Adductor canal block', 'type': 'PROCEDURE', 'description': 'Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.', 'armGroupLabels': ['Levobupivacaine', 'Placebo']}, {'name': 'Levobupivacaine', 'type': 'DRUG', 'description': 'Levobupivacaine', 'armGroupLabels': ['Levobupivacaine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '10 ml of sodium chloride 0.9%', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3435CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Leon Timmerman, dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Antonius Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Following publication of the results, for at least 15 years.', 'ipdSharing': 'YES', 'description': 'Following publication of the results, anonymized IPD (all study results) will be available for meta-analyses upon request.', 'accessCriteria': 'Data will be available on request. If a journal allows online sharing of IPD with a publication, this will be considered as well.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., PhD, principal investigator', 'investigatorFullName': 'Leon Timmerman', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}