Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 4:52 PM
Study NCT ID:
NCT05984433
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D064386', 'term': 'Ankle Fractures'}], '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'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020831', 'term': 'Acupuncture, Ear'}], 'ancestors': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055097', 'term': 'Auriculotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient will be under sedation during procedure, so will not be aware of whether or not they received acupuncture treatment.\n\nAnesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of group assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total opioid analgesic use for 14 days after surgery', 'timeFrame': '14 days', 'description': 'Total opioid given in hospital and taken at home, converted to oral morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '14 days', 'description': 'Pain scores (1-10) in PACU and at the 7 and 14 day mark post surgery'}, {'measure': 'Incidence of side effects associated with opioid use', 'timeFrame': '14 days', 'description': 'PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Fracture, Ankle', 'Pilon Fracture of Tibia', 'Foot Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient ages 18-64\n2. American Society of Anesthesiology Physical Status I, II or III\n3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital\n\nExclusion Criteria:\n\n1. Renal dysfunction (Serum Cr \\> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications\n2. Allergy to any of the standard anesthetic agents\n3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)\n4. Patient or surgeon refusal'}, 'identificationModule': {'nctId': 'NCT05984433', 'briefTitle': 'Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Auricular Acupuncture As Part Of A Multimodal Analgesic Regimen For Reduction Of Opioid Analgesic Use After Surgery To Repair Lower Leg Fractures- A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-53820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroauricular acupuncture', 'description': 'Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.', 'interventionNames': ['Device: Auricular acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'No acupuncture', 'description': 'No acupuncture treatment given'}], 'interventions': [{'name': 'Auricular acupuncture', 'type': 'DEVICE', 'description': 'Electro auricular acupuncture', 'armGroupLabels': ['Electroauricular acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaime Ortiz, MD,MBA', 'role': 'CONTACT', 'email': 'jaimeo@bcm.edu', 'phone': '713-873-2860'}, {'name': 'Jaime Ortiz, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ben Taub Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jaime Ortiz, MD, MBA', 'role': 'CONTACT', 'email': 'jaimeo@bcm.edu', 'phone': '713-873-2860'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Jaime Ortiz', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}