Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2026-01-03 @ 4:01 AM
Study NCT ID:
NCT02855567
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Charles.ascher-walsh@mssm.edu', 'phone': '212-241-2827', 'title': 'Dr. Charles Ascher-Walsh', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'Acupuncture', 'description': 'Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Acupuncture', 'description': 'Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Morphine Equivalent Usage While in the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': 'Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.'}], 'classes': [{'title': 'Intra-operative', 'categories': [{'measurements': [{'value': '29.59', 'spread': '14.42', 'groupId': 'OG000'}, {'value': '30.82', 'spread': '12.47', 'groupId': 'OG001'}]}]}, {'title': '24 hours Post-operative', 'categories': [{'measurements': [{'value': '10.54', 'spread': '8.33', 'groupId': 'OG000'}, {'value': '11.74', 'spread': '10.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intra-operative and 24 hours post-operatively', 'description': 'Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively. Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Pain Medication Tablets Used at Home Post-Operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': 'Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.'}], 'classes': [{'title': 'oxycodone/acetaminophen tablets', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '8'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'ibuprofen tablets', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15.5'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '7 days post-operatively', 'description': 'Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.', 'unitOfMeasure': 'tablets', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Readmitted to the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': 'Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post-operatively', 'description': 'Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': 'Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.'}], 'classes': [{'title': 'Hour 0', 'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '2.04', 'upperLimit': '3.85'}, {'value': '4.05', 'groupId': 'OG001', 'lowerLimit': '3.19', 'upperLimit': '4.90'}]}]}, {'title': 'Hour 1', 'categories': [{'measurements': [{'value': '4.27', 'groupId': 'OG000', 'lowerLimit': '3.48', 'upperLimit': '5.06'}, {'value': '4.50', 'groupId': 'OG001', 'lowerLimit': '3.67', 'upperLimit': '5.33'}]}]}, {'title': 'Hour 2', 'categories': [{'measurements': [{'value': '3.49', 'groupId': 'OG000', 'lowerLimit': '2.69', 'upperLimit': '4.29'}, {'value': '3.61', 'groupId': 'OG001', 'lowerLimit': '2.80', 'upperLimit': '4.42'}]}]}, {'title': 'Hour 4', 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '2.09', 'upperLimit': '4.12'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 4 hours post operatively', 'description': 'Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score at Home Post-Operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': 'Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.62', 'groupId': 'OG000', 'lowerLimit': '3.97', 'upperLimit': '5.28'}, {'value': '5.27', 'groupId': 'OG001', 'lowerLimit': '4.65', 'upperLimit': '5.88'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '4.18', 'groupId': 'OG000', 'lowerLimit': '3.53', 'upperLimit': '4.84'}, {'value': '4.40', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': '5.02'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '3.60', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '4.25'}, {'value': '3.73', 'groupId': 'OG001', 'lowerLimit': '3.11', 'upperLimit': '4.35'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '3.03', 'groupId': 'OG000', 'lowerLimit': '2.36', 'upperLimit': '3.69'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.37', 'upperLimit': '3.63'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '1.95', 'upperLimit': '3.28'}, {'value': '2.38', 'groupId': 'OG001', 'lowerLimit': '1.75', 'upperLimit': '3.00'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '2.21', 'groupId': 'OG000', 'lowerLimit': '1.55', 'upperLimit': '2.88'}, {'value': '2.06', 'groupId': 'OG001', 'lowerLimit': '1.43', 'upperLimit': '2.68'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000', 'lowerLimit': '1.26', 'upperLimit': '2.59'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '1.13', 'upperLimit': '2.38'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 7 days post operatively', 'description': 'Pain Score from 0-10 with higher score indicating more pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acupuncture', 'description': 'Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.'}, {'id': 'FG001', 'title': 'Sham Acupuncture', 'description': 'Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acupuncture', 'description': 'Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.'}, {'id': 'BG001', 'title': 'Sham Acupuncture', 'description': 'Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.99', 'spread': '10.84', 'groupId': 'BG000'}, {'value': '48.58', 'spread': '12.52', 'groupId': 'BG001'}, {'value': '45', 'spread': '11.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.17', 'spread': '6.95', 'groupId': 'BG000'}, {'value': '27.34', 'spread': '6.64', 'groupId': 'BG001'}, {'value': '27.22', 'spread': '6.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prior abdominal surgery', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Indication for surgery', 'classes': [{'title': 'Abnormal Uterine Bleeding (AUB)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Adnexal mass', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Bulk', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Infertility', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Prolapse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-19', 'size': 645431, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-24T14:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2016-07-29', 'resultsFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-24', 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Equivalent Usage While in the Hospital', 'timeFrame': 'Intra-operative and 24 hours post-operatively', 'description': 'Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively. Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.'}], 'secondaryOutcomes': [{'measure': 'Number of Pain Medication Tablets Used at Home Post-Operatively', 'timeFrame': '7 days post-operatively', 'description': 'Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.'}, {'measure': 'Number of Patients Readmitted to the Hospital', 'timeFrame': '2 weeks post-operatively', 'description': 'Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.'}, {'measure': 'Pain Score', 'timeFrame': 'up to 4 hours post operatively', 'description': 'Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain'}, {'measure': 'Pain Score at Home Post-Operatively', 'timeFrame': 'up to 7 days post operatively', 'description': 'Pain Score from 0-10 with higher score indicating more pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['surgery', 'acupuncture', 'gynecology', 'pain', 'narcotics'], 'conditions': ['Post-operative Pain', 'Gynecological Surgery', 'Acupuncture']}, 'descriptionModule': {'briefSummary': 'This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.', 'detailedDescription': 'The goal of the study is to investigate acupuncture at the time of gynecological surgery as a way to decrease post-operative pain which would decrease narcotic intake and hospitalization time. To do this, the researchers will recruit non-pregnant patients over the age of 18 who are undergoing laparoscopic surgery for a benign gynecological indication. These patients will be randomized using a computer generated randomization system to receive either acupuncture or sham acupuncture pre-operatively after the induction of anesthesia. The acupuncture points used will be points proven in the literature to be associated with decreasing general pain, pelvic pain and nausea and vomiting. The needles will be placed by a anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while the patient is prepped for the surgery. The sham points will be on the hands and feet and chosen at random by the gynecologic surgeon who is not trained in acupuncture. For both groups, the acupuncture needles will be removed before the first incision of the surgery. All patients will be blinded to their group allocation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients\n* over the age of 18\n* scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa\n\nExclusion Criteria:\n\n* male patients\n* pregnancy\n* suspected or known malignant disease\n* immunocompromised\n* known or persistent abuse of medications, drugs or alcohol\n* chronic pain for greater than 3 months'}, 'identificationModule': {'nctId': 'NCT02855567', 'briefTitle': 'Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients', 'orgStudyIdInfo': {'id': 'GCO 16-1120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture', 'description': 'Receives acupuncture during gynecological surgery at 5 known points for pain control. Needles will be placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient is prepped for surgery. They will be in place for 15 minutes.', 'interventionNames': ['Device: Acupuncture needles']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture', 'description': 'Receives acupuncture during gynecological surgery at sham points not associated with pain control. Needles will be placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles will be removed immediately after placement.', 'interventionNames': ['Device: Acupuncture needles']}], 'interventions': [{'name': 'Acupuncture needles', 'type': 'DEVICE', 'description': 'Acupuncture needles (29 and 30 gauge) used to perform the acupuncture', 'armGroupLabels': ['Acupuncture', 'Sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Charles Ascher-Walsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}