Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-02 @ 1:20 AM
Study NCT ID:
NCT04065451
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2019-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Epinephrine on Post-polypectomy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rlahr@iu.edu', 'phone': '317-948-0724', 'title': 'Clinical Research Specialist', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '* Number of patients in study was small but sample size calculation was performed prior to initiating the study.\n* Study conducted by single experienced endoscopist which might limit generalizability.\n* Blinding to the use of epinephrine proved to not be possible due to the blanching effect of epinephrine.'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Patients were assessed for adverse events that occurred within 30 days after the procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'delayed bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immediate Post-polypectomy Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid'}, {'id': 'OG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '32.4', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '25.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after the procedure', 'description': 'Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Immediate Post Polypectomy Pain (1hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid'}, {'id': 'OG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '27.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour after procedure', 'description': 'Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'en Bloc Resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Polyps', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid'}, {'id': 'OG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}], 'classes': [{'title': 'En bloc removal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Piecemeal removal', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the colonoscopy procedure, an average of 47.3 minutes', 'description': 'Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)', 'unitOfMeasure': 'Polyps', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Polyps', 'denomUnitsSelected': 'Polyps', 'populationDescription': 'One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.'}, {'type': 'SECONDARY', 'title': 'Sydney Resection Quotient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'Polyps', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid'}, {'id': 'OG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '6.3'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the colonoscopy procedure, an average of 47.3 minutes', 'description': 'size of the polyp in mm divided by the number of pieces the polyps is removed in', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Polyps', 'denomUnitsSelected': 'Polyps', 'populationDescription': 'Only lesions removed by EMR with electrocautery (heat) are included.'}, {'type': 'SECONDARY', 'title': 'Quality of the Mound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Polyps', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid'}, {'id': 'OG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}], 'classes': [{'title': 'Excellent/adequate', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'insufficient', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'During the colonoscopy procedure, an average of 47.3 minutes', 'description': 'Endoscopist impression of lift provided by the submucosal injection: excellent/adequate or insufficient. Excellent is the best rating and insufficient is the worst rating on this scale.', 'unitOfMeasure': 'Polyps', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Polyps', 'denomUnitsSelected': 'Polyps', 'populationDescription': 'One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.'}, {'type': 'SECONDARY', 'title': 'Frequency of Immediate Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Polyps', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid'}, {'id': 'OG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}], 'classes': [{'title': 'Bleeding', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'No bleeding', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'During the colonoscopy procedure, an average of 47.3 minutes', 'description': 'Number of polyps with intraprocedural bleeding during removal', 'unitOfMeasure': 'Polyps', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Polyps', 'denomUnitsSelected': 'Polyps', 'populationDescription': 'One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid'}, {'id': 'FG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Twenty-two patients consented to participate in the trial, but two patients were not randomized to either of the study arms. One patient did not have a polyp to remove (referred polyp was a lipoma). The other patient had poor bowel preparation, and the procedure was aborted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'units': 'Other Units (Polyps)', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)\n\nEpinephrine: Epinephrine in the submucosal injection fluid'}, {'id': 'BG001', 'title': 'No Epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Not Reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Polyp Size', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '28.3', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '16.1', 'groupId': 'BG001'}, {'value': '43.7', 'spread': '23.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Other Units (Polyps)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-19', 'size': 282901, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-04T11:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-20', 'studyFirstSubmitDate': '2019-08-15', 'resultsFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-20', 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate Post-polypectomy Pain', 'timeFrame': '30 minutes after the procedure', 'description': 'Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain'}, {'measure': 'Immediate Post Polypectomy Pain (1hour)', 'timeFrame': '1 hour after procedure', 'description': 'Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain'}], 'secondaryOutcomes': [{'measure': 'en Bloc Resection', 'timeFrame': 'During the colonoscopy procedure, an average of 47.3 minutes', 'description': 'Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)'}, {'measure': 'Sydney Resection Quotient', 'timeFrame': 'During the colonoscopy procedure, an average of 47.3 minutes', 'description': 'size of the polyp in mm divided by the number of pieces the polyps is removed in'}, {'measure': 'Quality of the Mound', 'timeFrame': 'During the colonoscopy procedure, an average of 47.3 minutes', 'description': 'Endoscopist impression of lift provided by the submucosal injection: excellent/adequate or insufficient. Excellent is the best rating and insufficient is the worst rating on this scale.'}, {'measure': 'Frequency of Immediate Bleeding', 'timeFrame': 'During the colonoscopy procedure, an average of 47.3 minutes', 'description': 'Number of polyps with intraprocedural bleeding during removal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Polyp']}, 'referencesModule': {'references': [{'pmid': '23022496', 'type': 'BACKGROUND', 'citation': 'Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25.'}, {'pmid': '26077453', 'type': 'BACKGROUND', 'citation': 'ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.'}, {'pmid': '28061339', 'type': 'BACKGROUND', 'citation': 'Klein A, Bourke MJ. How to Perform High-Quality Endoscopic Mucosal Resection During Colonoscopy. Gastroenterology. 2017 Feb;152(3):466-471. doi: 10.1053/j.gastro.2016.12.029. Epub 2017 Jan 3. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization. Epinephrine (for use with local anaesthetics). Model Prescribing Information: Drugs Used in Anaesthesis, Geneva, 1989:33'}, {'pmid': '34896443', 'type': 'DERIVED', 'citation': 'Rex DK, Lahr RE, Peterson MM, Vemulapalli KC. Impact of including epinephrine in the submucosal injectate for colorectal EMR on postprocedural pain: a randomized controlled trial. Gastrointest Endosc. 2022 Mar;95(3):535-539.e1. doi: 10.1016/j.gie.2021.11.043. Epub 2021 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'Epinephrine is widely used in endoscopic mucosal resection of large polyps to prevent post-polypectomy bleeding. No previous studies looked at increase in immediate post-polypectomy pain with the use of epinephrine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Patients aged 18 years and over\n2. Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps\n3. Able to sign informed consent\n\nExclusion Criteria\n\n1. Patients previously enrolled in the study\n2. Pedunculated polyps\n3. Polyps not amenable to endoscopic resection\n4. Patients allergic or sensitive to epinephrine\n5. Patients with coronary artery disease who have had a myocardial infarction in the past year, or had coronary stenting in the past year, or had angina in the past year.\n6. Patients electing anesthesia other than monitored anesthesia care with propofol (MAC) for colonoscopy'}, 'identificationModule': {'nctId': 'NCT04065451', 'briefTitle': 'Effect of Epinephrine on Post-polypectomy Pain', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Effect of Epinephrine on Immediate Post-polypectomy Pain in Colorectal Lesions Larger Than 20 mm', 'orgStudyIdInfo': {'id': '1908473351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epinephrine', 'description': 'Epinephrine in the submucosal injection fluid (1:200,000)', 'interventionNames': ['Drug: Epinephrine']}, {'type': 'NO_INTERVENTION', 'label': 'No epinephrine', 'description': 'Submucosal injection fluid without epinephrine'}], 'interventions': [{'name': 'Epinephrine', 'type': 'DRUG', 'description': 'Epinephrine in the submucosal injection fluid', 'armGroupLabels': ['Epinephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Douglas K Rex, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Douglas K. Rex', 'investigatorAffiliation': 'Indiana University'}}}}