Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-18 @ 10:42 PM
Study NCT ID:
NCT02315261
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2014-12-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015360', 'term': 'Analgesia, Epidural'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'minkcheerful@hotmail.com', 'phone': '66824197995', 'title': 'Dr.Mingkwan Wongyingsinn', 'phoneExt': '81', 'organization': 'Faculty of Medicine Siriraj Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 days', 'eventGroups': [{'id': 'EG000', 'title': 'Epidural Group', 'description': 'Patients age \\> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital', 'otherNumAtRisk': 364, 'deathsNumAtRisk': 364, 'otherNumAffected': 213, 'seriousNumAtRisk': 364, 'deathsNumAffected': 0, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Postoperative nausea and vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 100}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 109}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dural puncture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Epidural Group', 'description': 'Patients age \\> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at postoperative 24 hours', 'description': 'Verbal Rating Scale Pain will routinely be assessed at postoperative 24 hours by the ward nurse.\n\nMinimum and maximum scores possible are 0 and 10. The higher values represent patients having more pain. Severe pain is defined as Verbal Rating Scale pain at rest more than 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Requiring Rescue Analgesic Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Epidural Group', 'description': 'Patients age \\> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during the period of retaining of epidural catheter up to 3 days after operation', 'description': 'Number of patients requiring at least one rescue analgesic medication including epidural catheter, oral and intravenous route after the operation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration Retaining Epidural Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Epidural Group', 'description': 'Patients age \\> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital'}], 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000', 'lowerLimit': '53.9', 'upperLimit': '57.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'the period of retaining of epidural catheter up to 3 days after operation', 'description': 'Duration retaining epidural catheter in hospital', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Adverse Effects and Postoperative Complications.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Epidural Group', 'description': 'Patients age \\> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital'}], 'classes': [{'title': 'Postoperative nausea and vomiting', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Accidental dural puncture', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Post-dural puncture headache', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'the period of retaining of epidural catheter up to 3 days after operation', 'description': 'All Adverse Effects and Postoperative Complications included the number of patients having postoperative nausea and vomiting; hypotension; accidental dural puncture and post-dural puncture headache.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Epidural Group', 'description': 'Patients age \\> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Epidural Group', 'description': 'Patients age \\> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '242', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '5.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA physical classification', 'classes': [{'title': 'ASA physical status I', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'ASA physical status II', 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}]}]}, {'title': 'ASA physical status III', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}, {'title': 'ASA physical status IV', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The ASA physical status classification system is a system for assessing the fitness of patients before surgery. In 1963 the American Society of Anesthesiologists (ASA) adopted this category physical status classification system as\n\nASA physical status I: Healthy person. ASA physical status II: Mild systemic disease. ASA physical status III: Severe systemic disease. ASA physical status IV: Severe systemic disease that is a constant threat to life.', 'unitOfMeasure': 'Participants'}, {'title': 'Surgical site', 'classes': [{'title': 'Thoracic', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'Upper abdomen', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}]}]}, {'title': 'Lower abdomen', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}]}]}, {'title': 'Whole abdomen', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of surgery', 'classes': [{'categories': [{'measurements': [{'value': '192', 'spread': '85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2014-12-04', 'resultsFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2014-12-09', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-16', 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7', 'timeFrame': 'at postoperative 24 hours', 'description': 'Verbal Rating Scale Pain will routinely be assessed at postoperative 24 hours by the ward nurse.\n\nMinimum and maximum scores possible are 0 and 10. The higher values represent patients having more pain. Severe pain is defined as Verbal Rating Scale pain at rest more than 7.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Requiring Rescue Analgesic Medication', 'timeFrame': 'during the period of retaining of epidural catheter up to 3 days after operation', 'description': 'Number of patients requiring at least one rescue analgesic medication including epidural catheter, oral and intravenous route after the operation'}, {'measure': 'Duration Retaining Epidural Catheter', 'timeFrame': 'the period of retaining of epidural catheter up to 3 days after operation', 'description': 'Duration retaining epidural catheter in hospital'}, {'measure': 'All Adverse Effects and Postoperative Complications.', 'timeFrame': 'the period of retaining of epidural catheter up to 3 days after operation', 'description': 'All Adverse Effects and Postoperative Complications included the number of patients having postoperative nausea and vomiting; hypotension; accidental dural puncture and post-dural puncture headache.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epidural analgesia', 'Pain score'], 'conditions': ['Analgesia Disorder', 'Anesthetic Complication Epidural', 'Adverse Reaction to Epidural Anesthesia']}, 'referencesModule': {'references': [{'pmid': '27501608', 'type': 'DERIVED', 'citation': 'Wongyingsinn M, Anuwongjaroen A. Effectiveness of Postoperative Epidural Analgesia for Thoracic and Abdominal Surgery in Siriraj Hospital. J Med Assoc Thai. 2016 May;99(5):531-8.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.', 'detailedDescription': 'Epidural analgesia is the recommended perioperative analgesia in patients having major surgery in order to significantly reduced pain scores, minimize patient distress and can accelerate postoperative recovery especially with the major operation This technique has been reported to provide better pain control and less postoperative fatigue compared with patients receiving general anesthesia alone.Additionally, it is recommended in patients having major surgery to allow patients to mobilize quickly and have effective mobilization.This technique has been shown to be highly efficient at preventing postoperative ileus and various complications. Moreover, epidural analgesic technique is demonstrated to be safer and have fewer side effects than using intravenous opioids alone.\n\nHowever, the epidural technique is not universally successful and the number of patients experiencing inadequate analgesia with this technique is approximately 12-32%. The failure of epidural analgesia is still a frequent clinical problem and needs active management including a new block or other analgesic medication in order to rescue postoperative pain. Previous study showed that the incidence of patients having epidural analgesia with postoperative moderate pain was 20.9% and that with severe pain was 7.8%. In Siriraj Hospital, recent study showed that 19.6% of patients having elective upper abdominal surgery under general anesthesia combined with epidural analgesia reported severe first pain scores in post anesthetic care unit.27 As a result of severe pain, patients needed a number of intervention and management from acute pain service, and finally spent longer time in post anesthetic care unit.\n\nInadequate pain control in patients receiving epidural analgesia frequently occurred in clinical practice but the number of the success rate or the failure rate have not been reported in our hospital. This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged more than 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital\n\nExclusion Criteria:\n\n* inability to communicate or inform pain score\n* cesarean section or labor analgesia\n* additional analgesic techniques (spinal analgesia, paravertebral nerve block, intercostal block, transversus abdominis plane block, rectus sheath block, ilioinguinal block, iliohypogastric block\n* emergency surgery\n* fail epidural block after test dose of local anesthetics'}, 'identificationModule': {'nctId': 'NCT02315261', 'briefTitle': 'Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery in Siriraj Hospital', 'orgStudyIdInfo': {'id': 'SIRB004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Elective Thoracic and Abdominal Surgery Patients', 'type': 'PROCEDURE', 'otherNames': ['Epidural Analgesia'], 'description': 'This is an observational audit, reviewing the implementation of a standard care practice and requiring de-identified data collection in Elective Thoracic and Abdominal Surgery Patients only. All collected data will be that which is routinely part of normal clinical practice. The Research staff will systematically collect data on each patient. Some information can be obtained from the medical record, intraoperative anesthetic record, acute pain service record, etc whereas other information has to be obtained from direct observation at the bedside.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Mingkwan Wongyingsinn, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor, Doctor', 'investigatorFullName': 'Mingkwan Wongyingsinn, MD', 'investigatorAffiliation': 'Siriraj Hospital'}}}}