Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-24 @ 7:18 PM
Study NCT ID:
NCT04104204
Status:
UNKNOWN
Last Update Posted:
2020-02-27
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guided Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first analgesic request (PCA fentanyl)', 'timeFrame': '48 hours', 'description': 'Whether ultrasound guided supra-inguinal fascia iliaca block can increase pain free period of patients undergo total hip replacement under spinal block compare with intrathecal morphine or not'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '48 hours', 'description': 'Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative'}, {'measure': 'Amount of rescue analgesic drugs', 'timeFrame': '48 hours', 'description': 'Amount of PCA fentanyl'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total hip replacement', 'Ultrasound guided supra-inguinal fascia iliaca block', 'Intrathecal morphine', 'postoperative pain'], 'conditions': ['Total Hip Replacement', 'Ultrasound Guided Supra-inguinal Fascia Iliaca Block', 'Intrathecal Morphine', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Total hip replacement is one of major orthopedic surgery which result in severe postoperative pain especially at first 24 hours. Ultrasound guided regional anesthesia has become a part of multimodal analgesia.Ultrasound guided supra-inguinal fascia iliaca block is a new technique which can consistently cover femoral and lateral femoral cutaneous nerve. And with large volume (40ml), it may cover obturator nerve. This technique already proved to be useful for acute pain control in hip fracture or postoperative control in dynamic hip screw or nail insertion operation. However, it has not been compared with intrathecal morphine for total hip replacement yet.', 'detailedDescription': 'By using combine ultrasound guided supra-inguinal fascia iliaca block with periarticular infiltration with mutimodal analgesic drugs will have longer duration time to first rescue analgesic drug compared with combine intrathecal morphine with periarticular infiltration with multimodal analgesic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective surgery of primary total hip replacement, body weight ≥40kg and BMI ≤35 kg/m2, competence to consent\n\nExclusion Criteria:\n\n* contraindication to regional anesthesia, allergy to study drugs, skin infection at supra-inguinal fascia iliaca injection point, neurological deficit affecting the lower extremities, inability to use patient-controlled analgesia, GFR \\<50 mL/min'}, 'identificationModule': {'nctId': 'NCT04104204', 'briefTitle': 'The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guided Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guide Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Si 404/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Intrathecal morphine', 'description': 'Intrathecal morphine 0.1 mg, A sham subcutaneous injection of 0.5 ml normal saline at inguinal area', 'interventionNames': ['Drug: Intrathecal morphine']}, {'type': 'EXPERIMENTAL', 'label': 'Ultrasound guided supra-inguinal fascia iliaca block', 'description': '0.25% bupivacaine 40 ml', 'interventionNames': ['Drug: Ultrasound guided supra-inguinal fascia iliaca block']}], 'interventions': [{'name': 'Intrathecal morphine', 'type': 'DRUG', 'description': '0.5% Iso/Hyperbaric bupivacaine 2-3 ml add morphine 0.1 mg for spinal anesthesia', 'armGroupLabels': ['Intrathecal morphine']}, {'name': 'Ultrasound guided supra-inguinal fascia iliaca block', 'type': 'DRUG', 'description': 'Ultrasound guided supra-inguinal fascia iliaca block with 0.25% bupivacaine 40 ml and 0.5% Iso/Hyperbaric bupivacaine 2-3 ml without spinal morphine for spinal anesthesia', 'armGroupLabels': ['Ultrasound guided supra-inguinal fascia iliaca block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Pawinee Pangthipampai, M.D.', 'role': 'CONTACT', 'email': 'pawinee141@gmail.com', 'phone': '66864001721'}, {'name': 'Pawinee Pangthipampai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siriraj hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Pawinee Pangthipampai, M.D.', 'role': 'CONTACT', 'email': 'pawinee141@gmail.com', 'phone': '+6686 400 1721'}], 'overallOfficials': [{'name': 'Pawinee Pangthipampai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}