Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT06671028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mixed Local for Sciatic Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000083', 'term': 'Acetanilides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete sensory block', 'timeFrame': 'Tested every 2 min up to 60 min', 'description': 'The primary outcome is onset time for achievement of complete sensory block of the sciatic nerve determined via pinch test.'}], 'secondaryOutcomes': [{'measure': 'Duration of analgesia', 'timeFrame': 'up to 48 hours after discharge', 'description': 'Patient self reported time to onset of pain or analgesics'}, {'measure': 'Pain score at 6 hour post-block', 'timeFrame': '6 hours after nerve block', 'description': 'Numeric rating scale of patient self-reported pain at 6 hour after block placement'}, {'measure': 'Patient satisfaction', 'timeFrame': 'at 48 hour', 'description': '5 point categorical'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Regional Anesthesia', 'Local Anesthetic']}, 'referencesModule': {'references': [{'pmid': '17356507', 'type': 'BACKGROUND', 'citation': 'Bugamelli S, Zangheri E, Montebugnoli M, Borghi B, Ricci A, De Simone N, Bonfatti M, Elmar K, Luppi M, Pignotti E. One-day surgery for acquired forefoot deformity: sciatic nerve blockade with mepivacaine vs mepivacaine+ropivacaine: a prospective, randomized study. Minerva Anestesiol. 2007 Jan-Feb;73(1-2):57-64.'}, {'pmid': '19151302', 'type': 'BACKGROUND', 'citation': "Cuvillon P, Nouvellon E, Ripart J, Boyer JC, Dehour L, Mahamat A, L'hermite J, Boisson C, Vialles N, Lefrant JY, de La Coussaye JE. A comparison of the pharmacodynamics and pharmacokinetics of bupivacaine, ropivacaine (with epinephrine) and their equal volume mixtures with lidocaine used for femoral and sciatic nerve blocks: a double-blind randomized study. Anesth Analg. 2009 Feb;108(2):641-9. doi: 10.1213/ane.0b013e31819237f8."}, {'pmid': '23904938', 'type': 'BACKGROUND', 'citation': 'Valery P, Aliaksei M. A comparison of the onset time of complete blockade of the sciatic nerve in the application of ropivacaine and its equal volumes mixture with lidocaine: a double-blind randomized study. Korean J Anesthesiol. 2013 Jul;65(1):42-7. doi: 10.4097/kjae.2013.65.1.42. Epub 2013 Jul 19.'}, {'pmid': '22985391', 'type': 'BACKGROUND', 'citation': 'Chen L, Wang Q, Shi K, Liu F, Liu L, Ni J, Fang X, Xu X. The effects of lidocaine used in sciatic nerve on the pharmacodynamics and pharmacokinetics of ropivacaine in sciatic nerve combined with lumbar plexus blockade: a double-blind, randomized study. Basic Clin Pharmacol Toxicol. 2013 Mar;112(3):203-8. doi: 10.1111/bcpt.12008. Epub 2012 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'Choice of local anesthetics is the major determinant of the characteristics of a peripheral nerve block. Short acting local anesthetics while provides faster onset suffer from shorter duration. On the other hand, long acting local anesthetics while provides long duration suffered from long onset time. The ideal local anesthetics should provide faster nerve block onset while providing reasonable duration to provide sustained postoperative analgesia. Mixing short and long acting local anesthetics for nerve blocks may appear to be the solution however previous published studies have demonstrated similar onset time to long acting local anesthetics and with reduced duration. Recently, the London Health Sciences Centre established an ambulatory surgical centre. Fast onset peripheral nerve block is desirable. Previous studies have not looked at popliteal sciatic block and anecdotally we feel addition of short acting local anesthetics appear to speed up onset. We are therefore interested in conducting a randomize trial to determine whether mixing short and long acting local anesthetics can speed up onset of surgical quality block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years old)\n* Scheduled for elective below-knee surgeries such as ankle arthroscopy, lower limb fracture fixation, toe surgeries, etc\n* Capable of providing informed consent\n\nExclusion Criteria:\n\n* History of allergic reaction to local anesthetics\n* Pre-existing neurological disorders affecting lower limbs\n* Significant renal or hepatic impairment\n* Pregnancy or breastfeeding\n* Less than 60kg\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06671028', 'briefTitle': 'Mixed Local for Sciatic Block', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Ropivacaine Versus Ropivacaine with Lidocaine Mixture in Poplitial-Sciatic Nerve Block for Below Knee Surgeries- a Randomized, Single Center Study', 'orgStudyIdInfo': {'id': '125572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine', 'description': 'Popliteal block using Ropivacaine 100 mg in 20 mL', 'interventionNames': ['Drug: Ropivacaine 0,5%']}, {'type': 'EXPERIMENTAL', 'label': 'Ropivacaine anmd Lidocaine', 'description': 'Popliteal sciatic block using Ropivacaine 100 mg and Lidocaine 100 mg in 20 mL', 'interventionNames': ['Drug: Ropivacaine and Lidocaine']}], 'interventions': [{'name': 'Ropivacaine and Lidocaine', 'type': 'DRUG', 'description': 'Popliteal sciatic block using Ropivacaine 100 mg and Lidocaine 100 mg in 20 mL', 'armGroupLabels': ['Ropivacaine anmd Lidocaine']}, {'name': 'Ropivacaine 0,5%', 'type': 'DRUG', 'description': 'Popliteal sciatic block using ropivacaine 0.5% 20 mL', 'armGroupLabels': ['Ropivacaine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cheng Lin', 'role': 'CONTACT', 'email': 'cheng.lin@lhsc.on.ca', 'phone': '5196858500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This will require REb approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Cheng Lin', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}