Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-03 @ 2:24 AM
Study NCT ID:
NCT01449318
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2011-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2011-10-07', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain scores from IV insertion', 'timeFrame': '15 minutes prior to induction'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': '24 to 48 hours before surgery'}, {'measure': 'Pain from thermal stimuli', 'timeFrame': '24 to 48 hours before surgery', 'description': 'Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.'}, {'measure': 'Suprathreshold Thermal pain intensity', 'timeFrame': '24 to 48 hours before surgery', 'description': 'Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm'}, {'measure': 'suprathreshold thermal unpleasantness intensity', 'timeFrame': '24 to 48 hours before surgery'}, {'measure': 'Expectation about pain', 'timeFrame': '24 to 48 hours before surgery'}, {'measure': 'postoperative pain', 'timeFrame': 'within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery', 'description': 'Postoperative pain will be measured upon arrival to the Post Anesthesia Care Unit (PACU)before morphine consumption and after morphine consumption, at rest and at movement.'}, {'measure': 'Morphine consumption', 'timeFrame': 'within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'quantitative sensory testing'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception.', 'detailedDescription': 'Psychological factors and experimental pain models such as as electrical, pressure, heat, or cold stimuli have been identified as predictors of pain intensity and opioid consumption postoperatively. This study will investigate, in addition to the factors described above, the ability of pain scores generated from painful stimuli postoperatively in predicting postoperative pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing abdominal hysterectomy through a pfannenstiel incision\n* American Society of Anesthesiologists (ASA)Class I-III\n\nExclusion Criteria:\n\n* Patients with a history of psychiatric disease\n* Diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies\n* chronic opioid or nonsteroidal antiinflammatory drug use\n* chronic pain conditions'}, 'identificationModule': {'nctId': 'NCT01449318', 'briefTitle': 'Predictors of Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Predictors of Postoperative Pain Following Abdominal Hysterectomy', 'orgStudyIdInfo': {'id': 'ANES.MA.13'}, 'secondaryIdInfos': [{'id': 'AUBMC', 'type': 'OTHER', 'domain': 'AUBMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Patients undergoing hysterectomy', 'interventionNames': ['Device: Thermal Sensory Analyzer (Senselab)']}], 'interventions': [{'name': 'Thermal Sensory Analyzer (Senselab)', 'type': 'DEVICE', 'otherNames': ['Modular Sensory Analyzer, Senselab'], 'description': 'Thermal stimuli will be administered to the ventral surface of the dominant forearm and then to the lower abdomen (surgical site)using the Thermal Sensory Analyser. Each thermal testing trial will be separated by approximately 2 min and at a separate site.\n\nTo measure the thermal pain threshold temperature, The thermode will be applied to the ventral surface of the dominant forearm and the temperature will be increased at 1°C/s from 35 to 50°C.\n\nTo measure the Suprathreshold Thermal Pain Intensity and unpleasantness, Stimulus responses for noxious heat stimuli will be performed by applying phasic heat stimuli at 8 different temperatures (35, 43, 44, 45, 46, 47, 48, and 49°C).', 'armGroupLabels': ['Patients undergoing hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American Unversity of Beirut Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'AUBMC', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Marie T Aouad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}