{ "FullStudy":{ "Rank":218045, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513447", "OrgStudyIdInfo":{ "OrgStudyId":"STU00057039" }, "Organization":{ "OrgFullName":"Northwestern University", "OrgClass":"OTHER" }, "BriefTitle":"Intracutaneous Sterile Water Injections", "OfficialTitle":"Intracutaneous Sterile Water Injection as an Adjunct to Neuraxial Labor Analgesia: A Randomized Controlled Trial" }, "StatusModule":{ "StatusVerifiedDate":"February 2015", "OverallStatus":"Terminated", "WhyStopped":"low qualified candidate enrollment", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 30, 2015", "ResultsFirstSubmitQCDate":"February 23, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 2, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 23, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 2, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Cynthia Wong", "ResponsiblePartyInvestigatorTitle":"Professor of Anesthesiology", "ResponsiblePartyInvestigatorAffiliation":"Northwestern University" }, "LeadSponsor":{ "LeadSponsorName":"Northwestern University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"For most women, the most significant pain they will experience is the pain associated with childbirth. Up to one-third of women experience \"back labor\", this typically occurs when the fetus assumes varying degrees of malposition, especially the occiput posterior position, and causes additional constant pressure against the maternal spine and pelvis. \"Back labor\" presents as constant pain, that occurs even between contractions. It is often difficult to manage, by the patient, the obstetrician, and the anesthesiologist, and may increase the rate of instrumental and caesarian delivery.\n\nEpidural anesthesia/analgesia is the most common and effective intervention used to help women cope with labor pain. Dilute concentrations of local anesthetic and opioid provide complete analgesia for most women. Some women, however, have breakthrough pain, often due to \"back labor,\" and require more concentrated drug solutions. This increases the side effects associated with these drugs (e.g., hypotension, pruritus, motor block), thus treatment of this pain poses a challenge for the anesthesiologist and the obstetrician.\n\nSterile water injections (SWI) are a simple and well-established method of managing labor pain among midwives. This intervention was first used to alleviate pain associated with kidney stones, and was introduced to obstetrics in the 1970s. Using a syringe, small amounts of sterile water is deposited subcutaneously near the sacral area. The sterile water causes osmotic and mechanical irritation resulting in a brief (15-30 second) and significant stinging sensation. The onset of pain relief follows almost immediately and may last for up to two hours. The procedure can be repeated a number of times.\n\nSterile water for pain management is most often administered using four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 cm below and 1-2 cm medial to the original two injection sites. 0.1 mL of sterile water is injected between the dermal layers to raise a small bleb on the skin surface at each of the four sites. In labor, the injections are administered sequentially during a uterine contraction, with the series of four injections, performed two at a time, completed within 20-30 seconds.\n\nThe investigators hypothesize that the use of sterile water injections in women with neuraxial analgesia with breakthrough pain will result in decreased local anesthetic requirements and increase patient satisfaction.", "DetailedDescription":"Since it is assumed that the neuraxial anesthetic is placed prior to transition to active phase of labor, the patient will receive the intervention when they report breakthrough pain. Prior to administration of the intervention, the adequacy of the existing neuraxial anesthetic will be verified as bilateral decreased discrimination to cold from T8 to the sacrum. Four tuberculin syringes, each containing 0.1 mL of the assigned solution labeled \"study drug\" will be prepared. Patients allocated to the study group will receive sterile water, and those allocated to the control group will receive sterile normal saline solution.\n\nThe area to be injected will be prepared with chlorhexidine wipes to ensure sterility. In the sitting position, study subjects will receive a total of 0.4 mL of \"study drug\" via four injections: bilateral injections at the posterior superior iliac spine on and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nPatients will be asked to rate their overall labor pain using a 0-100 mm visual analog scale (VAS) for pain prior to study drug administration and every 30 minutes until commencement of pushing. They will also be asked to specifically rate low back pain with the VAS. Analgesia administration data from the time of study drug injection, including maintenance epidural solution volume, time of first patient controlled epidural analgesia (PCEA) bolus request, number of PCEA bolus requests and delivered doses, total PCEA bupivacaine dose, time to first request for manual rebolus, number of manual bolus doses, manual bolus bupivacaine dose, total bupivacaine dose and total fentanyl dose.\n\nAdditional recorded data will include maternal age, height, weight, cervical dilation at initiation of neuraxial analgesia and at study drug administration, duration of labor (initiation of analgesia to delivery), maximum oxytocin infusion rate during labor, and mode of delivery. A \"total labor pain score\" will be assessed approximately 60 minute after delivery, as well as satisfaction with labor analgesia using a 100-mm VAS." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Labor Pain" ] }, "KeywordList":{ "Keyword":[ "sterile water injections", "back labor" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"8", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Sterile Water Injection", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of \"study drug\" via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Intracutaneous injections" ] } },{ "ArmGroupLabel":"Normal Saline Injection", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of \"study drug\" via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Intracutaneous injections" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Intracutaneous injections", "InterventionDescription":"Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Normal Saline Injection", "Sterile Water Injection" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants With Breakthrough Back Labor Pain", "PrimaryOutcomeDescription":"It is anticipated that intracutaneous sterile water injections will provide additional pain relief as part of a multimodal analgesic regimen in women, especially in women with back labor.", "PrimaryOutcomeTimeFrame":"within 24 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Total Local Anesthetic Consumption", "SecondaryOutcomeDescription":"It is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.", "SecondaryOutcomeTimeFrame":"24 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nmultiparous women\nspontaneous labor\nat least 18 years of age\npresenting for vaginal delivery with cervical dilation of 4 centimeters or less\n\nExclusion Criteria:\n\nnulliparous\nless than 18 years old\ncontraindication to placement of neuraxial anesthetic\nskin infection in area to be injected\nmedical therapies considered to result in tolerance to opioids\nhistory of chronic pain (requiring regular medical follow-up with pain specialists)\nrecent use of opioid analgesics (within the year preceding pregnancy)", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Cynthia Wong, MD", "OverallOfficialAffiliation":"Northwestern University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Northwestern Memorial Hospital", "LocationCity":"Chicago", "LocationState":"Illinois", "LocationZip":"60611", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferenceType":"background", "ReferenceCitation":"Creehan PA. Pain relief and comfort measures in labor. In: Simpson KR, Creehan PA, editors. AWHONN's Perinatal Nursing, 3rd edn. Philadelphia, PA: Lippincott Williams & Wilkins; 2008. pp. 444-72." },{ "ReferencePMID":"3823471", "ReferenceType":"background", "ReferenceCitation":"Cervero F, Tattersall JE. Somatic and visceral sensory integration in the thoracic spinal cord. Prog Brain Res. 1986;67:189-205." },{ "ReferencePMID":"7039061", "ReferenceType":"background", "ReferenceCitation":"Bengtsson J, Worning AM, Gertz J, Struckmann J, Bonnesen T, Palludan H, Olsen PR, Frimodt-Møller C. [Pain due to urolithiasis treated by intracutaneous injection of sterile water. A clinically controlled double-blind study]. Ugeskr Laeger. 1981 Dec 14;143(51):3463-5. Danish." },{ "ReferencePMID":"1129076", "ReferenceType":"background", "ReferenceCitation":"Odent M. [Letter: Lumbar reflexotherapy. Efficacy in the treatment of nephrotic colic and in obstretrical analgesia]. Nouv Presse Med. 1975 Jan 18;4(3):188. French." },{ "ReferencePMID":"15295342", "ReferenceType":"background", "ReferenceCitation":"Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. Review." },{ "ReferencePMID":"7950471", "ReferenceType":"background", "ReferenceCitation":"Reynolds JL. Intracutaneous sterile water for back pain in labour. Can Fam Physician. 1994 Oct;40:1785-8, 1791-2." },{ "ReferencePMID":"5320816", "ReferenceType":"background", "ReferenceCitation":"Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. Review." },{ "ReferencePMID":"18308260", "ReferenceType":"background", "ReferenceCitation":"Mårtensson L, McSwiggin M, Mercer JS. US midwives' knowledge and use of sterile water injections for labor pain. J Midwifery Womens Health. 2008 Mar-Apr;53(2):115-22. doi: 10.1016/j.jmwh.2007.09.008." },{ "ReferencePMID":"19459860", "ReferenceType":"background", "ReferenceCitation":"Hutton EK, Kasperink M, Rutten M, Reitsma A, Wainman B. Sterile water injection for labour pain: a systematic review and meta-analysis of randomised controlled trials. BJOG. 2009 Aug;116(9):1158-66. doi: 10.1111/j.1471-0528.2009.02221.x. Epub 2009 May 14. Review." },{ "ReferencePMID":"21430035", "ReferenceType":"background", "ReferenceCitation":"Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Delivery of infant in less than 90 minutes from recruitment.", "FlowRecruitmentDetails":"Recruitment began 4/17/2012, ended 10/26/2012. Recruitment stopped due to low number of subjects meeting study criteria for entry.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Sterile Water Injection", "FlowGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Normal Saline Injection", "FlowGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Laboring women requesting labor analgesia", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Sterile Water Injection", "BaselineGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Normal Saline Injection", "BaselineGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"3" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"5" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"8" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"32", "BaselineMeasurementSpread":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"31", "BaselineMeasurementSpread":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"31", "BaselineMeasurementSpread":"7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Breakthrough Back Labor Pain", "OutcomeMeasureDescription":"It is anticipated that intracutaneous sterile water injections will provide additional pain relief as part of a multimodal analgesic regimen in women, especially in women with back labor.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"within 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Sterile Water Injection", "OutcomeGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Normal Saline Injection", "OutcomeGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"3" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.67", "OutcomeAnalysisStatisticalMethod":"Fisher Exact", "OutcomeAnalysisCINumSides":"2-Sided" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Total Local Anesthetic Consumption", "OutcomeMeasureDescription":"It is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"milliliters", "OutcomeMeasureTimeFrame":"24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Sterile Water Injection", "OutcomeGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Normal Saline Injection", "OutcomeGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"3" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"190", "OutcomeMeasurementSpread":"104" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"234", "OutcomeMeasurementSpread":"60" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.29", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"102", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-230", "OutcomeAnalysisCIUpperLimit":"171" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Adverse events were collected from intervention until delivery of infant, for up to 24 hours", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Sterile Water Injection", "EventGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"3", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"3" },{ "EventGroupId":"EG001", "EventGroupTitle":"Normal Saline Injection", "EventGroupDescription":"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.\n\nIntracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"5", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"5" } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Cynthia A. Wong, M.D.", "PointOfContactOrganization":"Northwestern University Feinberg School of Medicine", "PointOfContactEMail":"c-wong2@northwestern.edu", "PointOfContactPhone":"312-472-3585" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007246", "ConditionMeshTerm":"Infertility" },{ "ConditionMeshId":"D000048949", "ConditionMeshTerm":"Labor Pain" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010146", "ConditionAncestorTerm":"Pain" },{ "ConditionAncestorId":"D000009461", "ConditionAncestorTerm":"Neurologic Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" },{ "ConditionAncestorId":"D000005832", "ConditionAncestorTerm":"Genital Diseases, Male" },{ "ConditionAncestorId":"D000005831", "ConditionAncestorTerm":"Genital Diseases, Female" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8873", "ConditionBrowseLeafName":"Infertility", "ConditionBrowseLeafAsFound":"Sterile", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M24595", "ConditionBrowseLeafName":"Labor Pain", "ConditionBrowseLeafAsFound":"Labor Pain", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10987", "ConditionBrowseLeafName":"Neurologic Manifestations", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7527", "ConditionBrowseLeafName":"Genital Diseases, Male", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7526", "ConditionBrowseLeafName":"Genital Diseases, Female", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" } ] } } } } } }