Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-02 @ 1:33 AM
Study NCT ID:
NCT07000058
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006821', 'term': 'Hyaluronoglucosaminidase'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D011133', 'term': 'Polysaccharide-Lyases'}, {'id': 'D019757', 'term': 'Carbon-Oxygen Lyases'}, {'id': 'D008190', 'term': 'Lyases'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All the above selected are blind regarding the used technique of anesthesia'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of participants will receive WALANT technique;\n\n1. Group A (n=50); WALANT with Hyaluronidase\n2. Group B (n=50); WALANT without Hyaluronidase'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-05-23', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset time of analgesia.', 'timeFrame': 'from time of drug injection to start time of analgesia', 'description': 'time to start analgesia'}], 'secondaryOutcomes': [{'measure': 'Duration of postoperative analgesia', 'timeFrame': 'from onset time of analgesia to end of analgesia time postoperatively', 'description': 'duration of analgesia'}, {'measure': 'Pain intensity', 'timeFrame': 'from start of pain postoperatively till the end of first 24 hours postoperatively', 'description': 'Pain intensity measured by Numerical Rating Scale (NRS)'}, {'measure': 'The amount of morphine used', 'timeFrame': 'From start of postoperative pain to end of first 24 hours postoperatively', 'description': 'Dose of morphine used for analgesia postoperatively'}, {'measure': 'Amount of bleeding', 'timeFrame': 'From start of surgery to end of sugery', 'description': 'Volume of blood loss'}, {'measure': 'Patient satisfaction', 'timeFrame': 'From start of anesthesia till the end of first 24 hours postoperatively', 'description': 'Patient comfort with the technique'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['WALANT', 'Wide-Awake', 'Hand surgery', 'Hyaluronidase'], 'conditions': ['Hand Surgery', 'Local Infiltration']}, 'referencesModule': {'references': [{'pmid': '33778124', 'type': 'BACKGROUND', 'citation': 'Farzam R, Deilami M, Jalili S, Kamali K. Comparison of Anesthesia Results between Wide Awake Local Anesthesia no Tourniquet (WALANT) and Forearm Tourniquet Bier Block in Hand Surgeries: A Randomized Clinical Trial. Arch Bone Jt Surg. 2021 Jan;9(1):116-121. doi: 10.22038/abjs.2020.49526.2487.'}, {'pmid': '32258835', 'type': 'BACKGROUND', 'citation': "O'Neill N, Abdall-Razak A, Norton E, Kumar A, Shah H, Khatkar H, Alsafi Z, Agha R. Use of Wide-Awake Local Anaesthetic No Tourniquet (WALANT) in upper limb and hand surgery: A systematic review protocol. Int J Surg Protoc. 2020 Mar 13;20:8-12. doi: 10.1016/j.isjp.2020.03.001. eCollection 2020."}, {'pmid': '36836799', 'type': 'BACKGROUND', 'citation': 'Seretis K, Boptsi A, Boptsi E, Lykoudis EG. The Efficacy of Wide-Awake Local Anesthesia No Tourniquet (WALANT) in Common Plastic Surgery Operations Performed on the Upper Limbs: A Case-Control Study. Life (Basel). 2023 Feb 4;13(2):442. doi: 10.3390/life13020442.'}]}, 'descriptionModule': {'briefSummary': 'The WALANT (Wide Awake Local Anesthesia No Tourniquet) method, introduced by Dr. Donald H. Lalonde over a decade ago, has gained popularity due to its favorable outcomes and patient satisfaction. This technique involves injecting diluted lidocaine and epinephrine, which helps control pain and bleeding without the discomfort of a tourniquet.\n\nThis research will explore the use of hyaluronidase to enhance the WALANT technique. The study hypothesize that adding hyaluronidase would improve the onset speed and duration of pain control. A double-blinded study involving 100 patients compared WALANT with hyaluronidase (Group A) to WALANT without Hyaluronidase (Group B).', 'detailedDescription': 'Background: Hand surgery, being one of the most frequent outpatient procedures, remains undecided regarding the ideal anesthesia technique. Wide-Awake Local Anesthesia No Tourniquet (WALANT) is one of the frequently used anesthesia techniques by some hand surgeons (8%).\n\nObjective: The study aims to evaluate the impact of hyaluronidase administration on the onset and persistence of WALANT in hand surgery.\n\nPatients and Methods: This Prospective, randomized, double-blind clinical trial will be conducted in Souad Kafafi University Hospital (SKUH), faculty of medicine, Misr University for Science and Technology (MUST).\n\nOne hundred patients (18-60years old) with ASA class I or II who will be scheduled for hand surgery. They will be equally divided into two groups: Group A (n =50) WALANT with hyaluronidase technique: Patients will receive a mixture of hyaluronidase 15 IU to every 1 ml lidocaine 1% mixture. Group B (n =50) WALANT without hyaluronidase technique: Patients will receive a mixture of lidocaine 1%. The infiltrative local anesthesia will be administered at the appropriate site in subcutaneous tissue just deep to the incisional site to produce tumescent local anesthesia. The onset time and duration of postoperative analgesia will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* One hundred individuals scheduled for hand surgery\n* between the ages of 18 and 60 years old,\n* of both sexes\n* American Society of Anesthesiologists (ASA) classification I or II.\n* were randomized 1:1 to either Group A; (Receiving WALANT with hyaluronidase) or Group B; (Receiving WALANT without hyaluronidase).\n\nExclusion Criteria:\n\n* Pregnant women,\n* patients who refused the terms of the research consent statement,\n* psychiatric illness,\n* uncooperative patient,\n* patients with history of allergy to local anesthetic drugs,\n* cardiac arrhythmia,\n* patients with bleeding tendency,\n* patients with low flow finger perfusion state such as Burger disease and Raynaud's disease,\n* patients with connective tissue disease such as Scleroderma\n* suspicious disease with malignancy and hand infection"}, 'identificationModule': {'nctId': 'NCT07000058', 'briefTitle': 'Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Misr University for Science and Technology'}, 'officialTitle': 'Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery', 'orgStudyIdInfo': {'id': '2022/0103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (n=50): WALANT with Hyaluronidase', 'description': 'Patients received a mixture of hyaluronidase 15 IU to every 1 ml lidocaine 1% mixture (a solution composed of epinephrine 1:200,000 and lidocaine 1%). Buffered to reduce injection pain by 1 ml of sodium bicarbonate 8.4% for every 10 ml of the local anesthetic mixture.', 'interventionNames': ['Drug: Hyaluronidase and Lidocaine 1% mixture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (n=50): WALANT without Hyaluronidase:', 'description': 'A mixture of epinephrine 1:200,000 and lidocaine 1% buffered to reduce injection pain by 1 ml of sodium bicarbonate 8.4% for every 10 ml of the local anesthetic mixture.', 'interventionNames': ['Drug: lidocaine 1 % mixture']}], 'interventions': [{'name': 'Hyaluronidase and Lidocaine 1% mixture', 'type': 'DRUG', 'otherNames': ['Hyalase'], 'description': 'in group A hyaluronidase is expected to shorten the onset of action and prolong the duration of action of lidocaine 1% mixture than in group B where lidocaine 1% mixture only will be given', 'armGroupLabels': ['Group A (n=50): WALANT with Hyaluronidase']}, {'name': 'lidocaine 1 % mixture', 'type': 'DRUG', 'otherNames': ['Xylocaine 1%'], 'description': 'lidocaine 1 % mixture includes; A mixture of ( epinephrine 1:200,000 and lidocaine 1% ) buffered by 1 ml of sodium bicarbonate 8.4% for every 10 ml of the local anesthetic mixture.', 'armGroupLabels': ['Group B (n=50): WALANT without Hyaluronidase:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15525', 'city': 'Giza', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Misr University for Science and Technology', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Mohammed Hani Kamal, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Anesth.&pain'}, {'name': 'Mohammed Safwat Hamza, Ass. prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orthopedics'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After 5 months from today and wil be available for one year', 'ipdSharing': 'YES', 'description': 'Demographic Information: Age, sex, race, and other relevant demographic details.\n\nBaseline Characteristics: Health status, medical history, and any pre-existing conditions prior to the trial.\n\nTreatment Assignment: Information on the intervention or treatment each participant received.\n\nOutcome Measures: Data on primary and secondary outcomes as defined in the trial protocol.\n\nAdverse Events: Reports of any side effects or adverse events experienced by participants during the trial.\n\nFollow-up Data: Information collected during follow-up periods, including long-term outcomes.', 'accessCriteria': 'Researchers:\n\nWho: Academic researchers, industry scientists, and regulatory agencies. What: Full IPD, including demographic data, treatment assignments, and outcome measures.\n\nHow: Through data sharing platforms or repositories after submitting a research proposal and obtaining necessary approvals.\n\nRegulatory Authorities:\n\nWho: Agencies like the FDA or EMA. What: Full IPD and supporting documentation for oversight and review. How: Direct access during the review process of clinical trial applications.\n\nData Sharing Initiatives:\n\nWho: Collaborating institutions and consortia. What: Aggregated or anonymized IPD for meta-analyses or systematic reviews. How: Via established partnerships and shared databases.\n\nPublic and Patient Advocacy Groups:\n\nWho: Organizations seeking to promote transparency. What: Summary data and aggregated results, but not individual-level data. How: Through publicly available reports or dashboards.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia& pain', 'investigatorFullName': 'Emad Lotfy Mohammed Ahmed', 'investigatorAffiliation': 'Misr University for Science and Technology'}}}}