Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT03107559
Status:
UNKNOWN
Last Update Posted:
2017-05-23
First Post:
2017-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion Index and Labor Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-20', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relationship between Visual analogue scale and Perfüsion index', 'timeFrame': 'three month', 'description': 'Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia,'}], 'secondaryOutcomes': [{'measure': 'relationship between heart rate and Perfüsion index', 'timeFrame': 'three month', 'description': 'Determination of the relationship between heart rate and PI in patients with normal delivery who undergo epidural analgesia,'}, {'measure': 'relationship between non-invazive blood pressure and Perfüsion index', 'timeFrame': 'three month', 'description': 'Determination of the relationship between non-invazive blood pressure and PI in patients with normal delivery who undergo epidural analgesia,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perfüsion index', 'epidural analgesia', 'labor'], 'conditions': ['perfüsion Index in Removal of the Epidural Analgesia']}, 'referencesModule': {'references': [{'pmid': '18487245', 'type': 'BACKGROUND', 'citation': 'Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.'}, {'pmid': '16298532', 'type': 'BACKGROUND', 'citation': 'Tousignant-Laflamme Y, Marchand S. Sex differences in cardiac and autonomic response to clinical and experimental pain in LBP patients. Eur J Pain. 2006 Oct;10(7):603-14. doi: 10.1016/j.ejpain.2005.09.003. Epub 2005 Nov 18.'}, {'pmid': '19183409', 'type': 'RESULT', 'citation': 'Ledowski T, Ang B, Schmarbeck T, Rhodes J. Monitoring of sympathetic tone to assess postoperative pain: skin conductance vs surgical stress index. Anaesthesia. 2009 Jul;64(7):727-31. doi: 10.1111/j.1365-2044.2008.05834.x. Epub 2009 Jan 28.'}, {'pmid': '14694870', 'type': 'RESULT', 'citation': 'Bird J. Selection of pain measurement tools. Nurs Stand. 2003 Dec 10-16;18(13):33-9. doi: 10.7748/ns2003.12.18.13.33.c3515.'}, {'pmid': '24550680', 'type': 'RESULT', 'citation': 'Nishimura T, Nakae A, Shibata M, Mashimo T, Fujino Y. Age-related and sex-related changes in perfusion index in response to noxious electrical stimulation in healthy subjects. J Pain Res. 2014 Feb 10;7:91-7. doi: 10.2147/JPR.S57140. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'It can be suggested that sympathetic tonus increase and pain, caused by the removal of the effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose of this study is; To correlate the VAS value at the time of return of epidural analgesia with the PI values at that time and, to test the possibility of using PI variants as an objective tool for predicting pain initiation time and assessing pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 women between the ages of 18-45 who will give normal spontaneous vaginal delivery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women who will give normal spontaneous vaginal delivery\n* Between the ages of 18-45\n\nExclusion Criteria:\n\n* Patients who do not accept the procedure,\n* those under 18 years of age - over 45 years,\n* those with low platelet counts,\n* those with infection at the puncture site,\n* those with progressive neurological disease,\n* Those with increased intracranial pressure,\n* those with hypovolemia'}, 'identificationModule': {'nctId': 'NCT03107559', 'briefTitle': 'Perfusion Index and Labor Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan University'}, 'officialTitle': 'Can the Perfusion Index be Used as an Objective Instrument for the Assessment of Pain in the Labor Analgesia?', 'orgStudyIdInfo': {'id': 'ERZINCAN UNIVERSITY pain&pi'}}, 'armsInterventionsModule': {'interventions': [{'name': 'perfüsion index', 'type': 'DIAGNOSTIC_TEST', 'description': 'Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzincan', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ufuk kuyrukluyıldız', 'role': 'CONTACT', 'phone': '+904462122222'}], 'facility': 'Erzincan University', 'geoPoint': {'lat': 39.73919, 'lon': 39.49015}}], 'centralContacts': [{'name': 'ilke kupeli', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '5555485632'}], 'overallOfficials': [{'name': 'ilke kupeli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erzincan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assist. prof.', 'investigatorFullName': 'ILKE KUPELI', 'investigatorAffiliation': 'Erzincan University'}}}}