Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-13 @ 11:19 PM
Study NCT ID:
NCT06721000
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-30
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Control Epidural Versus Conventional Epidural.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue score', 'timeFrame': '24 hours', 'description': "Patient satisfaction will be assessed after 2hours, 12hours and 24hours after surgery according to patient's pain intensity.\n\nScore will be from 1-10, 10 means maximum satisfaction and 1 means minimal satisfaction."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient control epidural analgesia', 'Conventional epidural'], 'conditions': ['Post Operative Pain, Acute', 'Sedation Score', 'Degree of Motor Block', 'Length of Hospital Stay', 'Amount of Analgesic Used']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.5507/bp.2018.068', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "As one of the complications of THR is post operative pain, which usually requires epidural catheter insertion.\n\nWe are comparing the effect of patient control epidural versus conventional epidural for patient's satisfaction.", 'detailedDescription': 'More than 20 years of successful usage of epidural analgesia for post operative pain treatment include intermittent provider-administer bolus, patient control analgesia and continuous epidural infusion with or without patient control epidural analgesia. The main drawback of conventional epidural infusion is that it does not allow for individual variation in management of pain. As a result, patient control epidural analgesia has replaced it in recent years.3. It has been demonstrated that continuous epidural infusion with patient control epidural analgesia is highly effective at providing consistent analgesia, improving patient satisfaction, and reducing the workload of anesthesia provider but it is linked to higher local anesthetic consumption4 In patient undergoing THR, patient control epidural analgesia may be considered as an appropriate alternative for managing post operative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient population will be from liaquat national hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge \\>18 years. ASA 1-2 on pre anesthesia evaluation. Spontaneous breathing. Spo2 \\>95% Informed consent for participation.\n\nExclusion Criteria:\n\nA history of long-term opioid therapy (use of opioid analgesic at doses higher than codeine 120mg/day, hydrocodone 40mg/day, tramadol 200mg/day or oxycodone 40mg/day 0-4 days before surgery).\n\nIndication of revision surgery during immediate post operative care. Acute skin disease. Patients' refusal. ASA 3 and 4. Hypersensitivity to study drugs."}, 'identificationModule': {'nctId': 'NCT06721000', 'briefTitle': 'Patient Control Epidural Versus Conventional Epidural.', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat National Hospital & Medical College'}, 'officialTitle': 'Patient Control Epidural Versus Conventional Epidural After Total Hip Replacement', 'orgStudyIdInfo': {'id': 'App # 0881- 2023- LNH - ERC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCEA group', 'description': 'Epidural catheter is inserted and patient is given a remote to control the amount of drug given through patient control epidural pump.'}, {'label': 'Non-PCEA group', 'description': 'Epidural catheter is inserted and the amount of drug set will be delivered via infusion pump.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Liaquat national hospital and medical college', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "Considering patient's status of understanding i will decide it later."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaquat National Hospital & Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Uruba', 'investigatorFullName': 'Uruba Shamshad', 'investigatorAffiliation': 'Liaquat National Hospital & Medical College'}}}}