Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-04 @ 8:52 PM
Study NCT ID:
NCT01405768
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
2011-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'massadl@wudosis.wustl.edu', 'phone': '314-362-3181', 'title': 'L. Stewart Massad, M.D.', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '* Small sample - may have missed a significant difference when one really exists\n* Procedures performed by 2nd year residents vs. procedure performed by more skilled surgeon (less pain)\n* Used needle extenders/27-gauge needles vs. Potocki needles'}}, 'adverseEventsModule': {'timeFrame': 'Start of procedures through 30 days after completion of procedure. The procedure occurs on Day 1.', 'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine Arm', 'description': 'Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Buffered Lidocaine', 'description': 'Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.\n\nsodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Injection Pain Score (Mean)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Arm', 'description': 'Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.'}, {'id': 'OG001', 'title': 'Buffered Lidocaine', 'description': 'Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.\n\nsodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '19', 'groupId': 'OG000'}, {'value': '19', 'spread': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.13', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes of completion of procedure', 'description': 'A Likert visual analog scale will be used to document each study participant\'s level of pain experienced during injection of the cervical block.\n\nWithin 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.\n\nPatient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Arm', 'description': 'Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.'}, {'id': 'OG001', 'title': 'Buffered Lidocaine', 'description': 'Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.\n\nsodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.'}], 'classes': [{'title': 'Injection pain', 'categories': [{'measurements': [{'value': '25', 'spread': '19', 'groupId': 'OG000'}, {'value': '19', 'spread': '17', 'groupId': 'OG001'}]}]}, {'title': 'Procedure pain', 'categories': [{'measurements': [{'value': '27', 'spread': '18', 'groupId': 'OG000'}, {'value': '19', 'spread': '17', 'groupId': 'OG001'}]}]}, {'title': 'Cramping pain', 'categories': [{'measurements': [{'value': '19', 'spread': '16', 'groupId': 'OG000'}, {'value': '18', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes of completion of procedure', 'description': 'A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.\n\nWithin 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.\n\nPatient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Injection Pain Score (Median)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Arm', 'description': 'Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.'}, {'id': 'OG001', 'title': 'Buffered Lidocaine', 'description': 'Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.\n\nsodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '75'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '60'}]}]}], 'analyses': [{'pValue': '.13', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 30 minutes of completion of the procedure', 'description': 'A Likert visual analog scale will be used to document each study participant\'s level of pain experienced during injection of the cervical block.\n\nWithin 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.\n\nPatient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Arm', 'description': 'Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.'}, {'id': 'OG001', 'title': 'Buffered Lidocaine', 'description': 'Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.\n\nsodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.'}], 'classes': [{'title': 'Injection pain', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '75'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '60'}]}]}, {'title': 'Procedure pain', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '63'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '54'}]}]}, {'title': 'Cramping pain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '62'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 30 minutes of completion of procedure', 'description': 'A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.\n\nWithin 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.\n\nPatient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Arm', 'description': 'Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.'}, {'id': 'FG001', 'title': 'Buffered Lidocaine', 'description': 'Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.\n\nsodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': "Didn't complete questionnaire correctly", 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine Arm', 'description': 'Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.'}, {'id': 'BG001', 'title': 'Buffered Lidocaine', 'description': 'Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.\n\nsodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '32.3', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latina', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parity', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '2+', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Parity indicates the number of \\>20-week births (including viable and non-viable; i.e., stillbirths). Pregnancies consisting of multiples, such as twins or triplets, count as one birth for the purpose of this notation.', 'unitOfMeasure': 'participants'}, {'title': 'Indication', 'classes': [{'title': 'HSIL', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'CIN 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'CIN 3', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'AIS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Persistent CIN 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'HSIL = High grade squamous intraepithelial lesion\n\nCIN 2 = Cervical squamous intraepithelial neoplasia 2\n\nCIN 3 = Cervical squamous intraepithelial neoplasia 2\n\nAIS = Adenocarcinoma in situ\n\nPersistent CIN 1 = Persistent cervical squamous intraepithelial neoplasia 1', 'unitOfMeasure': 'participants'}, {'title': 'Procedure type', 'classes': [{'title': 'Ectocervix only', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Ectocervix and endocervix', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of passes', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': '3+', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ectocervical loop size (in mm)', 'classes': [{'title': '15 x 12', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '20 x 12', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Endocervical loop size (in mm)', 'classes': [{'title': '10 x 10', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': '15 x 12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '10 x 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '8 patients in the Lidocaine arm had the endocervical loop used.\n\n11 patients in the Buffered Lidocaine arm had the endocervical loop used.', 'unitOfMeasure': 'participants'}, {'title': 'Estimated blood loss (in mL)', 'classes': [{'title': '0 mL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': '1-5 mL', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': '6-10 mL', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': '>10 mL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Anesthetic volume (in mL)', 'classes': [{'title': '6-9 mL', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': '10 mL', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': '>10 mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '4 women from the lidocaine arm who did not complete the questionnaire correctly were excluded from analysis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2011-07-28', 'resultsFirstSubmitDate': '2014-05-19', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-26', 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Injection Pain Score (Mean)', 'timeFrame': 'Within 30 minutes of completion of procedure', 'description': 'A Likert visual analog scale will be used to document each study participant\'s level of pain experienced during injection of the cervical block.\n\nWithin 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.\n\nPatient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.'}, {'measure': 'Injection Pain Score (Median)', 'timeFrame': 'Within 30 minutes of completion of the procedure', 'description': 'A Likert visual analog scale will be used to document each study participant\'s level of pain experienced during injection of the cervical block.\n\nWithin 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.\n\nPatient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.'}], 'secondaryOutcomes': [{'measure': 'Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)', 'timeFrame': 'Within 30 minutes of completion of procedure', 'description': 'A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.\n\nWithin 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.\n\nPatient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.'}, {'measure': 'Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)', 'timeFrame': 'Within 30 minutes of completion of procedure', 'description': 'A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.\n\nWithin 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.\n\nPatient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uterine Cervical Dysplasia']}, 'referencesModule': {'references': [{'pmid': '19136338', 'type': 'BACKGROUND', 'citation': 'Ruegg TA, Curran CR, Lamb T. Use of buffered lidocaine in bone marrow biopsies: a randomized, controlled trial. Oncol Nurs Forum. 2009 Jan;36(1):52-60. doi: 10.1188/09.ONF.52-60.'}, {'pmid': '11927854', 'type': 'BACKGROUND', 'citation': 'Sharma T, Gopal L, Shanmugam MP, Bhende P, George J, Samanta TK, Mukesh BN. Comparison of pH-adjusted bupivacaine with a mixture of non-pH-adjusted bupivacaine and lignocaine in primary vitreoretinal surgery. Retina. 2002 Apr;22(2):202-7. doi: 10.1097/00006982-200204000-00011.'}, {'pmid': '8881789', 'type': 'BACKGROUND', 'citation': 'Fitton AR, Ragbir M, Milling MA. The use of pH adjusted lignocaine in controlling operative pain in the day surgery unit: a prospective, randomised trial. Br J Plast Surg. 1996 Sep;49(6):404-8. doi: 10.1016/s0007-1226(96)90011-9.'}, {'pmid': '16384767', 'type': 'BACKGROUND', 'citation': 'Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.'}, {'pmid': '15140310', 'type': 'BACKGROUND', 'citation': "Younis I, Bhutiani RP. Taking the 'ouch' out - effect of buffering commercial xylocaine on infiltration and procedure pain - a prospective, randomised, double-blind, controlled trial. Ann R Coll Surg Engl. 2004 May;86(3):213-7. doi: 10.1308/003588404323043382."}, {'pmid': '9771366', 'type': 'BACKGROUND', 'citation': 'Masters JE. Randomised control trial of pH buffered lignocaine with adrenaline in outpatient operations. Br J Plast Surg. 1998 Jul;51(5):385-7. doi: 10.1054/bjps.1997.0293.'}, {'pmid': '1430977', 'type': 'BACKGROUND', 'citation': 'Orlinsky M, Hudson C, Chan L, Deslauriers R. Pain comparison of unbuffered versus buffered lidocaine in local wound infiltration. J Emerg Med. 1992 Jul-Aug;10(4):411-5. doi: 10.1016/0736-4679(92)90269-y.'}], 'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for their cervical block will experience less injection pain than women who receive plain lidocaine.', 'detailedDescription': 'Specific aims:\n\n1. To determine whether buffering the agent used for intracervical anesthetic at the time of cervical loop excision reduces injection-related pain. (Hypothesis: buffering significantly reduces injection-related pain.)\n2. To determine whether other components of pain from LEEP (procedural pain, and cramping) can be reduced by buffering of intracervical anesthetic among women undergoing cervical loop excision. (Hypothesis: only injection pain will be reduced by buffering, as procedural pain will be reduced by lidocaine equally in both arms and cramping will not be reduced in either arm.)\n\nBackground:\n\nAlthough cervical cancer rates have been dramatically reduced by Pap test screening and the eradication of precursors, more than 100,000 U.S. women develop premalignant cervical lesions each year that require treatment (1). The cervical loop electrosurgical excision procedure (LEEP) is the most common therapy for CIN among U.S. gynecologists. LEEP is performed using one or more 1-2 cm electrosurgical diathermy loops to excise involved and at-risk cervical epithelium including underlying stroma containing glands. Destroying this tissue eliminates cells infected with human papillomavirus, the proximate cause of cervical cancer, and radically reduces the risk of later developing cervical cancer (2, 3).\n\nLEEP is usually performed as an outpatient procedure using intracervical anesthesia, most commonly combining lidocaine as an anesthetic agent with epinephrine as a hemostatic agent; final hemostasis is achieved using electrosurgical fulguration and topical hemostatic agents (4). Prior literature has suggested that pain from LEEP has 3 components: pain from injection of the anesthetic combination, pain from the excision, and cramping from reflex uterine contractions (5). While cramping can be controlled with oral nonsteroidal anti-inflammatory agents, injection and procedural pain are not. Most women categorize the pain of LEEP as 3-7 on a 0-10 Likert scale (5, 6).\n\nStudies of dermal and ocular anesthesia and bone marrow biopsy have found that buffering of acidic local anesthetic agents reduces injection pain (7-14), with up to 66% reduction in pain and significant results in randomized trials involving 30-50 participants. However, the use of buffered lidocaine has not yet been tested for LEEPs. The principal investigator has used both forms of anesthesia and considers both acceptable forms of therapy; he is unaware of any evidence to support the superiority of either arm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* antecedent biopsy read as\n\n * cervical intraepithelial neoplasia (CIN) grade 2 or 3 or microinvasive cancer\n * adenocarcinoma in situ\n * persistent CIN 1\n* antecedent pap read as\n\n * high grade squamous intraepithelial lesion\n * atypical glandular cells\n * persistent low grade squamous intraepithelial lesion\n\nExclusion Criteria:\n\n* anatomy unsuitable for safe office loop excision based on operator judgement\n* inability to tolerate procedure under local anesthesia\n* pregnancy\n* age less than 18 years\n* inability to understand spoken or written English\n* refusal of consent\n* prisoner\n* mental incapacity\n* anticoagulant or antiplatelet therapy, or known bleeding diathesis\n* use of analgesics other than over the counter medications(OTC meds include NSAIDS or Tylenol) within 7 days of scheduled LEEP'}, 'identificationModule': {'nctId': 'NCT01405768', 'briefTitle': 'Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Randomized Trial of Buffered vs Nonbuffered Lidocaine With Epinephrine for Cervical Loop Excision', 'orgStudyIdInfo': {'id': '201104269'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine Arm', 'description': 'Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.', 'interventionNames': ['Drug: Non-buffered lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Buffered Lidocaine', 'description': 'Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.', 'interventionNames': ['Drug: sodium bicarbonate buffered lidocaine']}], 'interventions': [{'name': 'sodium bicarbonate buffered lidocaine', 'type': 'DRUG', 'description': '8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.', 'armGroupLabels': ['Buffered Lidocaine']}, {'name': 'Non-buffered lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Lidocaine Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'L. Stewart Massad, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}