Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 4:39 PM
Study NCT ID:
NCT02059694
Status:
WITHDRAWN
Last Update Posted:
2014-12-19
First Post:
2014-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006821', 'term': 'Hyaluronoglucosaminidase'}, {'id': 'D007201', 'term': 'Indicator Dilution Techniques'}, {'id': 'D003766', 'term': 'Dental Occlusion'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], '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': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'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'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'lastUpdateSubmitDate': '2014-12-18', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain sensation', 'timeFrame': '5 minutes after injection', 'description': 'Test preparation will be applied subcutaneously in both upper eyelids by injection using a 30-gauge injection needle with the patient in supine position. Every patient will be injected by the same Oculoplastic surgeon.\n\nA second investigator (masked to the treatment condition of each eye) will test Pinprick pain Sensation 5 minutes after each injection using a sterile "finger stick" needle at three sites of each upper eyelid. These sites include medial, central and lateral portion of each eyelid, approximately 4 mm above the lid margin. The subject will be asked to rate the degree of pain experienced at each site on a scale from 0 (none) to 10 (severe).'}], 'secondaryOutcomes': [{'measure': 'Anesthesia duration', 'timeFrame': 'After procedure started', 'description': 'Patients will also be instructed to inform the surgeon of precisely when the pain began and subsided to accurately record the duration of the pain experienced.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Eyelid surgery', 'local block/anesthesia', 'hyaluronidase', 'Bilateral upper eyelid surgery', 'Duke Eye Centre', 'Duke Aesthetic Center'], 'conditions': ['Upper Eyelid Surgery']}, 'referencesModule': {'references': [{'pmid': '22984909', 'type': 'BACKGROUND', 'citation': 'Roberts MA, Mendez U, Gilbert RJ, Keim AP, Goldman J. Increased hyaluronan expression at distinct time points in acute lymphedema. Lymphat Res Biol. 2012 Sep;10(3):122-8. doi: 10.1089/lrb.2012.0001.'}, {'pmid': '22633726', 'type': 'BACKGROUND', 'citation': 'Rowlett J. Extravasation of contrast media managed with recombinant human hyaluronidase. Am J Emerg Med. 2012 Nov;30(9):2102.e1-3. doi: 10.1016/j.ajem.2012.03.005. Epub 2012 May 23.'}, {'pmid': '7798421', 'type': 'BACKGROUND', 'citation': 'Clark LE, Mellette JR Jr. The use of hyaluronidase as an adjunct to surgical procedures. J Dermatol Surg Oncol. 1994 Dec;20(12):842-4. doi: 10.1111/j.1524-4725.1994.tb03718.x.'}, {'pmid': '22456420', 'type': 'BACKGROUND', 'citation': 'Wohlrab J, Finke R, Franke WG, Wohlrab A. Efficacy study of hyaluronidase as a diffusion promoter for lidocaine in infiltration analgesia of skin. Plast Reconstr Surg. 2012 Apr;129(4):771e-772e. doi: 10.1097/PRS.0b013e318245ea27. No abstract available.'}, {'pmid': '11004052', 'type': 'BACKGROUND', 'citation': 'Kallio H, Paloheimo M, Maunuksela EL. Hyaluronidase as an adjuvant in bupivacaine-lidocaine mixture for retrobulbar/peribulbar block. Anesth Analg. 2000 Oct;91(4):934-7. doi: 10.1097/00000539-200010000-00031.'}, {'pmid': '8610868', 'type': 'BACKGROUND', 'citation': 'Nathan N, Benrhaiem M, Lotfi H, Debord J, Rigaud G, Lachatre G, Adenis JP, Feiss P. The role of hyaluronidase on lidocaine and bupivacaine pharmacokinetics after peribulbar blockade. Anesth Analg. 1996 May;82(5):1060-4. doi: 10.1097/00000539-199605000-00032.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.', 'detailedDescription': 'Subjects scheduled for bilateral upper eyelid surgery will be recruited from among the patients of the Duke Eye Center. After consent is obtained following full explanation of the research, subjects will be randomly assigned (1:1 ratio) on the day of the surgery to receive local anaesthesia by either with recombinant hyaluronidase (rHuPH20) or without it. Approximately 2 ml of prepared block will be infiltrated in both upper eyelids.\n\nDilutions (Blocks):\n\nA) 0.5 mL of lidocaine 2% with epinephrine 1:100,000 and 0.5 mL of marcaine 0.75% and 1 mL (150 U) of rHuPH20 for a total of 75 U/ml B) 2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20\n\nTest preparation will be applied subcutaneously in both upper eyelids by injection using a 30-gauge injection needle with the patient in supine position. Every patient will be injected by the same Oculoplastic surgeon.\n\nA Pinprick pain test will be perform 5 minutes after each injection using a sterile "finger stick" needle at three sites of each upper eyelid. These sites include medial, central and lateral portion of each eyelid, approximately 4 mm above the lid margin. The subject will be asked to rate the degree of pain experienced at each site on a scale from 0 (none) to 10 (severe). An average pain score will be calculated for each eyelid. This will help determine if one of the 2 dilutions have a faster anaesthetic effect.\n\nPatients will also be instructed to inform the surgeon of precisely when the pain began and subsided to accurately record the duration of the pain experienced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n* Capable and willing to provide consent\n* Has been scheduled for bilateral upper eyelid surgery\n* At least 18 years of age\n* Exclusion Criteria:\n* Unable or unwilling to give consent\n* Previous upper eyelid surgery\n* Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT02059694', 'briefTitle': "Use of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's Surgery", 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'The Application of Recombinant Human Hyaluronidase is Effective for the Use of Local Blocks for Eyelid Surgery', 'orgStudyIdInfo': {'id': 'Pro00051289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyaluronidase', 'description': 'Dilutions (Blocks):\n\n0.5 mL of lidocaine 2% with epinephrine 1:100,000 and 0.5 mL of marcaine 0.75% and 1 mL (150 U) of rHuPH20 for a total of 75 U/ml', 'interventionNames': ['Drug: Hyaluronidase']}, {'type': 'OTHER', 'label': 'Comparitor', 'description': '2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20', 'interventionNames': ['Other: 2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20']}], 'interventions': [{'name': 'Hyaluronidase', 'type': 'DRUG', 'otherNames': ['Dilutions (Blocks):', '0.5 mL of lidocaine 2% with epinephrine 1:100,000 and 0.5 mL of marcaine 0.75% and 1 mL (150 U) of rHuPH20 for a total of 75 U/ml'], 'armGroupLabels': ['Hyaluronidase']}, {'name': '2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20', 'type': 'OTHER', 'armGroupLabels': ['Comparitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}