Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-19 @ 7:57 AM
Study NCT ID:
NCT02925832
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2016-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'C005717', 'term': 'proxymetacaine'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure level of pain and discomfort during surgery', 'timeFrame': '1 hours', 'description': 'A simple pain scoring system will be used during the surgery (0: No pain; 1: Discomfort; 2: Pain).\n\nAssessment will be made by verbally asking the patient to score each step of the surgery i.e. scleral tunnel incision, capsulorhexis, hydrodissection, phacoemulsification, irrigation aspiration, intraocular lens implantation and stromal hydration'}], 'secondaryOutcomes': [{'measure': 'Number of patients where Supplemental anaesthesia was given', 'timeFrame': '1 hour', 'description': 'Pain score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.'}, {'measure': 'Level of surgeon satisfaction', 'timeFrame': '1 hour', 'description': '0: Poor,\n\n1. Adequate,\n2. Good'}, {'measure': 'Incidence of Surgical complications', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Deep topical fornix nerve block Anesthesia', 'Ropivacaine', 'Bupivacaine', 'Anaesthesia', 'Eye surgery blocks', 'Phacoemulsification'], 'conditions': ['Cataract Unilateral Pending Extraction', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract surgeries by phacoemulsification. In this study the investigators intend to compare ropivacaine and bupivacaine in various parameters during phacoemulsification.', 'detailedDescription': 'Prospective, study will be conducted on 100 patients undergoing elective cataract surgery by phacoemulsification under Deep topical fornix nerve block at Government medical college, Haldwani, India.\n\nWritten informed consent to participate in the study will be taken from all the patients.\n\nPatients will be randomly allocated into two groups, Groups B (Bupivacaine: n=50) and Group R (Ropivacaine: n =50).\n\nDeep topical fornix nerve block (DTFNB) would be performed using two sponges (2x3 mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anesthetizing the conjunctiva with proparacaine local anesthetic drops. The sponges are to be removed after 15-20 minutes. The anesthetic effect will be tested by grasping the limbus with Castroviejo 0.12 tissue forceps. No sedative systemic medications will be given to patients perioperatively.\n\nAll surgeries will be performed by the same surgeon. Both patients and surgeon will be blind to which anesthetic agent would be used. A 2.8mm scleral tunnel incision will be made, followed by capsulorhexis. The nucleus would be removed by the stop and chop technique followed by irrigation aspiration of the cortex. Foldable acrylic intraocular lens would be implanted in the capsular bag followed by wash of the viscoelastic and hydration of the side ports.\n\nA simple pain scoring system will be used during the surgery (0: No pain; 1: Discomfort; 2: Pain). Assessment will be made by verbally asking the patient to score each step of the surgery i.e. scleral tunnel Incision, capsulorhexis, hydrodissection, phacoemulsification, irrigation aspiration, intraocular lens implantation and stromal hydration.\n\nIn case the score being 0 or 1 no intervention will be done. But in cases of score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Anaesthesiologists Physical Status classification system (ASA I-II) to undergo planned cataract surgery by phacoemulsification.\n\nExclusion Criteria:\n\n* Younger than 50 years,\n* Had any psychiatric illness (including significant anxiety),\n* Nystagmus,\n* Insufficient pupil dilatation,\n* Very hard cataracts (NS 4-5),\n* Allergy to local anaesthetics,\n* Inability to understand language or\n* Patient refuses the topical anaesthesia technique'}, 'identificationModule': {'nctId': 'NCT02925832', 'acronym': 'DTFNB', 'briefTitle': 'Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification', 'organization': {'class': 'OTHER', 'fullName': 'Government Medical College, Haldwani'}, 'officialTitle': 'Comparison Between Ropivacaine and Bupivacaine in Deep Topical Fornix Nerve Block Anesthesia in Patients Undergoing Cataract Surgery by Phacoemulsification.', 'orgStudyIdInfo': {'id': '273/IEC/R-26.08.2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine', 'interventionNames': ['Procedure: Deep Topical Fornix Nerve block anesthesia', 'Drug: Bupivacaine', 'Drug: Proparacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group R', 'description': 'Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine', 'interventionNames': ['Procedure: Deep Topical Fornix Nerve block anesthesia', 'Drug: Ropivacaine', 'Drug: Proparacaine']}], 'interventions': [{'name': 'Deep Topical Fornix Nerve block anesthesia', 'type': 'PROCEDURE', 'otherNames': ['DTFNB'], 'description': 'DTFNB would be performed using two sponges (2x3mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with proparacaine local anaesthetic drops. The sponges are to be removed after 15 minutes.', 'armGroupLabels': ['Group B', 'Group R']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Local anaesthetic'], 'description': '0.75% ropivacaine soaked sponges', 'armGroupLabels': ['Group R']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Local anaesthetic'], 'description': '0.5% bupivacaine soaked sponges', 'armGroupLabels': ['Group B']}, {'name': 'Proparacaine', 'type': 'DRUG', 'otherNames': ['Local anesthetic'], 'description': 'For anaesthetising conjunctiva', 'armGroupLabels': ['Group B', 'Group R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '263139', 'city': 'Haldwani', 'state': 'Uttarakhand', 'country': 'India', 'facility': 'Government medical college', 'geoPoint': {'lat': 29.22254, 'lon': 79.5286}}], 'overallOfficials': [{'name': 'Govind S Titiyal, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of department Ophthalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Medical College, Haldwani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Graduate', 'investigatorFullName': 'Dr Rahul Varshney', 'investigatorAffiliation': 'Government Medical College, Haldwani'}}}}