Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-27 @ 1:17 AM
Study NCT ID:
NCT04971759
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-20', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'first analgesic request', 'timeFrame': '24 hours postoperative', 'description': 'time for the first analgesia rescue call.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine', 'Fentanyl']}, 'referencesModule': {'references': [{'pmid': '23160979', 'type': 'RESULT', 'citation': 'Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16.'}, {'pmid': '23355160', 'type': 'RESULT', 'citation': 'Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2481-6. doi: 10.1007/s00464-012-2761-y. Epub 2013 Jan 26.'}, {'pmid': '23389068', 'type': 'RESULT', 'citation': 'Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The perioperative management of pain following abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.', 'detailedDescription': 'As a result, the goal to reduce perioperative pain has taken on a multimodal approach.\n\nMultimodal or "balanced" analgesia uses a combination of opioid and nonopioid analgesics to improve pain control and minimize opioid-related side effects. These include the use of nonsteroidal anti-inflammatory drugs, local anesthetics, peripheral nerve blocks, gabapentinoids, and alpha2 adrenergic agonists. Any combination of these therapies can help reduce the surgical stress response and improve patient outcomes such as pain control, patient satisfaction, time to discharge, and return to daily activities.\n\nOne method used in this multimodal approach is the transversus abdominis plane block. As first described by Rafi in 2001, this block provides analgesia to the anterolateral abdominal wall. In 2007, further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid-mediated side effects. In this same year, Hebbard described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve TAP block accuracy. In 2008, Hebbard. described the subcostal approach of TAP blocks, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of abdominal surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status I, II, and III patients,\n* aged 60-75 y,\n* both male and female,\n* undergoing inguinal hernia repair surgery.\n\nExclusion Criteria:\n\n* morbid obesity (BMI \\> 40),\n* spine metastatic tumor, allergy to an amide LA, or magnesium sulfate,\n* heart block, renal, or liver dysfunction, substance abuse disorder, chronic opioid use, or electrolyte disturbance, administration of any sedative, preexisting mental illness, psychological or emotional problems.'}, 'identificationModule': {'nctId': 'NCT04971759', 'briefTitle': 'Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Addition of Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery: Could it Make a Difference?', 'orgStudyIdInfo': {'id': '17300618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group L', 'description': '30 Patients will receive Levobupivacaine 5%', 'interventionNames': ['Drug: Levobupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'LD group', 'description': '30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine.', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'LF group', 'description': '30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Levobupivacaine', 'type': 'DRUG', 'description': 'Levobupivacaine 5%', 'armGroupLabels': ['Group L']}, {'name': 'Dexmedetomidine Hydrochloride', 'type': 'DRUG', 'description': 'Levobupivacaine 5% + 1 µg/kg dexmedetomidine.', 'armGroupLabels': ['LD group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Levobupivacaine 5% + 1µg/kg fentanyl', 'armGroupLabels': ['LF group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut governorate', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ghada Mohammed AboelFadl', 'investigatorAffiliation': 'Assiut University'}}}}