Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00638404
Status:
TERMINATED
Last Update Posted:
2018-08-06
First Post:
2008-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Severity Postoperative Pain Prediction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ppan@wakehealth.edu', 'phone': '336-718-8278', 'title': 'Peter H. Pan MD, MSEE', 'organization': 'Wake Forest School of Medicine-Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1-elective Cesarean Sections', 'description': 'Elective Cesarean Sections-this portion completed', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 0, 'seriousNumAtRisk': 192, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3-inpatient Gynecologic Procedures', 'description': 'Any in-patient gynecologic procedure- this portion completed', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evoked Pain at 24 Hours VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-elective Cesarean Section', 'description': 'Elective Cesarean Sections-evoked pain score at 24 hours postoperative 0-100mmVAS'}, {'id': 'OG001', 'title': '3-inpatient Gynecologic Procedures', 'description': 'Any in-patient gynecologic procedure-'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '26', 'groupId': 'OG000'}, {'value': '49.3', 'spread': '30.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'anxiety to evoked pain is 0.24 (P\\<.001); anticipated pain to evoked pain is 0.33 (P\\<.001); anticipated pain medication to evoked pain is 0.33(P\\<.001).', 'nonInferiorityComment': 'correlation of anxiety, anticipated pain medication use and anticipated pain to 24 hour evoked pain measured'}, {'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'correlation of anxiety to evoked pain at 24 hour'}, {'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'correlation of anticipated pain medication 24 hour evoked pain measured'}, {'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'correlation of anticipated pain to 24 hour evoked pain measured'}], 'paramType': 'MEAN', 'timeFrame': 'evoked pain at 24 hours', 'description': 'Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'evoked pain outcome-measured on a scale of 0=no pain up to 100=most severe pain imaginable.'}, {'type': 'SECONDARY', 'title': 'Anticipated Pain Medication Requirement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-elective Cesarean Section', 'description': 'Elective Cesarean Sections-anticipated pain medication required postoperative evaluated during preoperative evaluation'}, {'id': 'OG001', 'title': '3-inpatient Gynecologic Procedures', 'description': 'Any in-patient gynecologic procedure-'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'groupDescription': 'preoperative questionnaire evaluating anticipated amount of pain medication potentially needed postoperatively; 0= none at all up to 100=as much as possible', 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anticipated Postoperative Pain at Preoperative Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-elective Cesarean Section', 'description': 'Elective Cesarean Sections-anticipated pain postoperative obtained during preoperative evaluation'}, {'id': 'OG001', 'title': '3-inpatient Gynecologic Procedures', 'description': 'Any in-patient gynecologic procedure-'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '26', 'groupId': 'OG000'}, {'value': '60.8', 'spread': '27.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'anticipated postoperative pain', 'description': 'anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-elective Cesarean Section', 'description': 'Elective Cesarean Sections preoperatively anxiety level'}, {'id': 'OG001', 'title': '3-inpatient Gynecologic Procedures', 'description': 'Any in-patient gynecologic procedure-preoperative anxiety level on a scale of 0-not anxious at all up to 100=most anxious'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '32', 'groupId': 'OG000'}, {'value': '57.5', 'spread': '34.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Spearman Correlation', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Correlation of'}], 'paramType': 'MEAN', 'timeFrame': 'anticipated anxiety prior to surgery', 'description': 'measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1-elective Cesarean Section', 'description': 'Elective Cesarean Sections-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively'}, {'id': 'FG001', 'title': '3-inpatient Gynecologic Procedures', 'description': 'Any in-patient gynecologic procedure-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '200 Elective cesarean sections and 100 gynecological patients were enrolled prior to their surgery with presurgical testing completed. All subjects were then also seen postoperatively for followup', 'preAssignmentDetails': 'no randomization, only observational study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1-elective Cesarean Sections', 'description': 'Elective Cesarean Sections-this portion completed'}, {'id': 'BG001', 'title': '3-inpatient Gynecologic Procedures', 'description': 'Any in-patient gynecologic procedure- this portion completed'}, {'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': '192', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '292', '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': '30', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '34.95', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '292', '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': '44', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'whyStopped': 'Further evaluation determined it was not feasible to enroll the post-partum tubal ligation group at our facility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2008-03-12', 'resultsFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-06', 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evoked Pain at 24 Hours VAS', 'timeFrame': 'evoked pain at 24 hours', 'description': 'Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain'}], 'secondaryOutcomes': [{'measure': 'Anticipated Pain Medication Requirement', 'timeFrame': '24 hours', 'description': 'measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required'}, {'measure': 'Anticipated Postoperative Pain at Preoperative Evaluation', 'timeFrame': 'anticipated postoperative pain', 'description': 'anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable'}, {'measure': 'Anxiety', 'timeFrame': 'anticipated anxiety prior to surgery', 'description': 'measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative somatic questions', 'Preoperative audio tone evaluations', 'Preoperative anxiety and previous experience with postop pain'], 'conditions': ['Anxiety', 'Pain', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity rating of audio tone will predict the severity of postoperative pain after surgery.', 'detailedDescription': 'The purpose of this study would be to determine the predictive value of a simple to perform preoperative evaluation in assessing level of anxiety, anticipated pain and the intensity rating of an audio tone to predict level of postoperative pain after surgery.\n\nStudy Design: A total of 400 evaluable patients will be studied using the various surgical populations listed. For statistical purposes, the following will be the surgical population by procedure. Two hundred healthy ASA I-II women scheduled for elective cesarean section, one hundred scheduled for elective postpartum tubal ligations, and one hundred scheduled for elective inpatient gynecological surgeries (such as total vaginal hysterectomy, total abdominal hysterectomy) will be consented and enrolled in the study. Normal baseline vital signs will be obtained and recorded as part of usual preoperative assessment for these patients. The patients will be asked about their current level of pain and to rate the intensity of a series of audio tones. At 18-24 hours postoperatively, and again at 36-48 hours postoperatively if applicable, research personnel will evaluate the severity of postoperative pain the patient has at rest and with movement (from supine to sitting upright), using a sliding pain scale from 0 to 100 mm, with 0 being no pain and 100 being the worst pain ever. Information on drug administered in the preoperative, intraoperative and postoperative period will be collected and recorded. The subject can also choose to allow us to follow-up with them in the future to evaluate current residual postoperative pain levels as needed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'scheduled for elective cesarean section, non-pregnant subjects scheduled for inpatient gynecological surgeries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy ASA physical status class 1 or 2\n* Aged 18 years or above\n* Pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections\n\nExclusion Criteria:\n\n* ASA \\>3\n* \\< 36 weeks for Cesarean Section\n* \\< 18 years of age'}, 'identificationModule': {'nctId': 'NCT00638404', 'briefTitle': 'Severity Postoperative Pain Prediction', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Predicting Severity of Postoperative Pain After Surgery', 'orgStudyIdInfo': {'id': 'Pain Prediction'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Elective Cesarean Sections-this portion completed'}, {'label': '3', 'description': 'Any in-patient gynecologic procedure- this portion completed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Peter H. Pan, MSEE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}