Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-28 @ 1:22 AM
Study NCT ID:
NCT04050059
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2019-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Analgesic Pretreatment Techniques Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2019-08-04', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score (Subjective)', 'timeFrame': 'After 10 minutes (right after spinal anesthesia procedure is complete)', 'description': 'Visual Analogue Scale pain Score in cm'}, {'measure': 'Pain Score (Objective)', 'timeFrame': 'During spinal anesthesia procedure', 'description': 'Objective scoring:\n\n1= No pain 2 = Mild flinch 3 = Wince 4= Yelp 5= Pulled away'}, {'measure': 'Maternal Satisfaction', 'timeFrame': 'After 10 minutes (right after spinal anesthesia procedure is complete)', 'description': 'Maternal Satisfaction Score (end of spinal anesthesia):\n\nVery Satisfied Satisfied No comments Unsatisfied Very Unsatisfied'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Spinal', 'Pain', 'Pregnancy', 'Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '10193230', 'type': 'BACKGROUND', 'citation': 'Koscielniak-Nielsen Z, Hesselbjerg L, Brushoj J, Jensen MB, Pedersen HS. EMLA patch for spinal puncture. A comparison of EMLA patch with lignocaine infiltration and placebo patch. Anaesthesia. 1998 Dec;53(12):1218-22. doi: 10.1046/j.1365-2044.1998.00608.x.'}, {'pmid': '8956393', 'type': 'BACKGROUND', 'citation': 'Sharma SK, Gajraj NM, Sidawi JE, Lowe K. EMLA cream effectively reduces the pain of spinal needle insertion. Reg Anesth. 1996 Nov-Dec;21(6):561-4.'}, {'type': 'BACKGROUND', 'citation': 'Wenk M, Massoth C, Weidlich S, Pöpping D M, Gurlit S, et al. Effects of local skin anaesthesia on pain during lumbar puncture. J Anaesthesiol Crit Care. 2017;1 (1):1-5'}, {'pmid': '8913402', 'type': 'BACKGROUND', 'citation': 'Juarez Gimenez JC, Oliveras M, Hidalgo E, Cabanas MJ, Barroso C, Moraga FA, Gallego S, de Toledo JS. Anesthetic efficacy of eutectic prilocaine-lidocaine cream in pediatric oncology patients undergoing lumbar puncture. Ann Pharmacother. 1996 Nov;30(11):1235-7. doi: 10.1177/106002809603001104.'}]}, 'descriptionModule': {'briefSummary': 'Nowadays lower segment cesarean sections are preferably carried out under regional anesthesia due to multiple advantages.\n\nLocal infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain.\n\nEMLA (eutectic mixture of local anesthetic) cream is the combination of lidocaine and prilocaine which have been effectively used in few studies to reduce needle prick pain.\n\nWe would like to see which analgesic pretreatment is superior in terms of reducing pain of spinal needle insertion and have better maternal satisfaction levels.', 'detailedDescription': 'OBJECTIVES: To compare the pain reduction and maternal satisfaction levels of two analgesic pretreatment modalities on pain reduction of spinal needle insertion i.e. 2% lidocaine infiltration and EMLA in patients undergoing elective LSCS.\n\nHypothesis: Analgesic pre-treatment with EMLA is superior to local skin infiltration with lidocaine'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Female pregnant patient planned for elective cesarean section under spinal anesthesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult women undergoing elective LSCS under spinal anesthesia\n\nExclusion Criteria:\n\n* BMI of more than 35 kg/m2\n* Contraindication to spinal anesthesia\n* Spinal deformity\n* Refusal of regional anesthesia\n* Patients with a history of back surgery\n* confirmed allergy to local anesthetics\n* More than three attempts of needle insertion for inducing spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT04050059', 'briefTitle': 'Comparison of Two Analgesic Pretreatment Techniques Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS.', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Comparison of Two Analgesic Pretreatment Techniques (2% Lidocaine Infiltration vs. EMLA Cream Application) Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS. A Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': '2019-1791-4956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2% Lidocaine group', 'description': 'In 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited) skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal anesthesia induction.', 'interventionNames': ['Drug: 2% lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EMLA cream group', 'description': 'In EMLA (Eutectic Mixture of Local Anesthesia- lidocaine 2.5% and prilocaine 2.5%) cream group, EMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion', 'interventionNames': ['Drug: EMLA cream']}], 'interventions': [{'name': 'EMLA cream', 'type': 'DRUG', 'description': 'EMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion', 'armGroupLabels': ['EMLA cream group']}, {'name': '2% lidocaine', 'type': 'DRUG', 'description': 'In 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited), skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal needle insertion', 'armGroupLabels': ['2% Lidocaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow Obstetric Anesthesiology', 'investigatorFullName': 'Dr. Malika Hameed', 'investigatorAffiliation': 'Aga Khan University'}}}}