Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 4:47 PM
Study NCT ID:
NCT00374504
Status:
COMPLETED
Last Update Posted:
2006-09-11
First Post:
2006-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Postoperative Pain by an Electrical Pain Stimulus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-02', 'lastUpdateSubmitDate': '2006-09-08', 'studyFirstSubmitDate': '2006-09-08', 'studyFirstSubmitQcDate': '2006-09-08', 'lastUpdatePostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '17430320', 'type': 'DERIVED', 'citation': 'Nielsen PR, Norgaard L, Rasmussen LS, Kehlet H. Prediction of post-operative pain by an electrical pain stimulus. Acta Anaesthesiol Scand. 2007 May;51(5):582-6. doi: 10.1111/j.1399-6576.2007.01271.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate a possible correlation between predictive precesarean section pain and development of postcaesarean section pain using the PM.\n\nPatients and Methods 46 healthy pregnant women scheduled for elective cesarean section is included after informed consent. The standard operation procedures included spinal anesthesia, paracetamol 1 g 8 hourly, diclofenac 50 mg 8 hourly and oxycontine 10 mg x 2. Morphine was used for break-through pain.\n\nBefore cesarian section the threshold for sensory and pain were measured 3 times, and the average was used for analyses. After cesarian section a blinded midwife assess the pain at rest and during mobilization every 12th hours over 2 days score.\n\nData was analyzed using AUC and non-parametric test, P \\< 0,05.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnant women scheduled for elective cesarean section\n\nExclusion Criteria:\n\n* ASA III -IV\n* Chronic pain conditions.\n* Pacemaker.'}, 'identificationModule': {'nctId': 'NCT00374504', 'briefTitle': 'Prediction of Postoperative Pain by an Electrical Pain Stimulus', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'orgStudyIdInfo': {'id': '01 2745584'}}, 'contactsLocationsModule': {'locations': [{'zip': 'dk-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital, Rrigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Per Rotbøll Nielsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}