Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-24 @ 5:04 AM
Study NCT ID:
NCT02505204
Status:
SUSPENDED
Last Update Posted:
2022-01-18
First Post:
2015-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PVB With vs. Without Clonidine for Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2015-07-20', 'studyFirstSubmitQcDate': '2015-07-21', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic stability recorded from electrocardiogram and pulse oximeter', 'timeFrame': 'within the first 48 hours after surgery', 'description': 'Compare the hemodynamic stability between the two groups'}], 'secondaryOutcomes': [{'measure': 'Postoperative nausea and vomiting recorded via questionnaire', 'timeFrame': 'within the first 48 hours after surgery', 'description': 'Comparison of postoperative nausea and vomiting between the two groups'}, {'measure': 'Postoperative analgesic consumption recorded via questionnaire', 'timeFrame': 'within the first 48 hours after surgery', 'description': 'Comparison of analgesic consumption between the two groups'}]}, 'conditionsModule': {'keywords': ['clonidine', 'paravertebral block', 'hemodynamic stability'], 'conditions': ['Ventral Hernia Repair']}, 'descriptionModule': {'briefSummary': 'Paravertebral block (PVB) combined with light intravenous sedation was associated with a short hospital stay, less post-operative nausea and vomiting and reduced analgesic consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with versus without clonidine in elderly patients.\n\nPatients will be randomly allocated to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive PVB with clonidine while group 2 will receive PVB with placebo.', 'detailedDescription': 'Introduction\n\nParavertebral block (PVB) showed to be successful in both children and adults. It has been reported to be an excellent pain reliever and it reduces post-operative nausea and vomiting, in patients undergoing breast surgery. PVB has proven to be very useful as a regional anesthetic technique when it comes to surgeries involving lumbar and thoracic dermatome. It was shown that the PVB combined with light intravenous sedation was associated with a short hospital stay, less post-operative nausea and vomiting (PONV) and reduced analgesic consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with versus without clonidine in elderly patients.\n\nObjectives:\n\nThe primary objective of this study is to compare the hemodynamic stability in a ventral hernia repair using paravertebral block with clonidine versus the PVB without clonidine.\n\nThe secondary objectives include a comparison of PONV and postoperative analgesic consumption.\n\nMaterials and Methods\n\nStudy design and sampling This is a prospective study with a randomized double- blinded design that will be conducted between August 2015 and August 2016.\n\nPatients scheduled for ventral hernia repair whose age is 65 years and older with American Society of Anesthesiologists (ASA) greater or equal to 2 will be included. Exclusion criteria comprised history of allergic reactions to local anesthetics, bleeding diatheses and spinal abnormality.\n\nPatients will be randomly allocated to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive PVB with clonidine while group 2 will receive PVB with placebo.\n\nAnesthetic techniques Since this trial is double-blinded, a specialized nurse will prepare the syringes for each patient.\n\nParavertebral nerve block techniques Bilateral nerve-stimulator PVB will be performed at the levels of T9-T10 or T9-T11 according to the type of ventral hernia and the planned incision type. The patient will be anesthetized in the lateral decubitus position. Supplemental oxygen will be given by facemask and regular anesthetic monitors will be attached.\n\nEach local anesthetic mixture will contain:\n\nFor group 1, the syringes will contain: lidocaine 2% 6 mL, lidocaine 2% 6 mL with epinephrine 5µg.mL-1, bupivacaine 0.5% 5 mL, fentanyl 1 mL (50µg) and clonidine 2 mL.\n\nAs for the group 2, the same anesthetic mixture will be administrated however the clonidine will be substituted with 2 mL saline.\n\nData collection\n\nDemographic data, ASA score, type and duration of surgery will be recorded. Haemodynamics will be registered such as the mean arterial blood pressure, heart rate and oxygen saturation, preoperatively (baseline), intra-operatively (incision of skin, dissection of hernia, traction over the sac and closure of incision) and postoperatively.\n\nAs for postoperative analgesia consumption, patients with a VAS score between three and four are given Tramadol Hydrochloride 50-100 mg every 4- 6 hours. If the VAS score is greater or equal to five, patients receive 1 mg/kg Dolosal.\n\nPost-operative nausea and vomiting will be recorded in the recovery room and in the regular ward. Pain assessment will be taken from patients by a verbal statement using Numeric Rating Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for ventral hernia repair whose age is 65 years and older\n* and with ASA greater or equal to 2\n\nExclusion Criteria:\n\n* History of allergic reactions to local anesthetics\n* Bleeding diatheses\n* Spinal abnormality'}, 'identificationModule': {'nctId': 'NCT02505204', 'briefTitle': 'PVB With vs. Without Clonidine for Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Makassed General Hospital'}, 'officialTitle': 'Paravertebral Block With Versus Without Clonidine for Patients Undergoing Ventral Hernia Repair: A Prospective Double-blinded Randomized Study', 'orgStudyIdInfo': {'id': '07/09/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clonidine', 'description': 'Will receive bilateral PVB with clonidine.', 'interventionNames': ['Other: Clonidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Will receive bilateral PVB with placebo.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Clonidine', 'type': 'OTHER', 'description': 'The anesthetic mixture will contain: lidocaine 2% 7 mL, lidocaine 2% 6 mL with epinephrine 5µg.mL-1, bupivacaine 0.5% 5 mL, and clonidine 2 mL.', 'armGroupLabels': ['Clonidine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'the same anesthetic mixture will be administrated however the clonidine will be substituted with 2 mL saline.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Makassed General Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Zoher Naja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chairperson of Anesthesia department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makassed General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairperson of Anesthesia and Pain Management Department', 'investigatorFullName': 'Zoher Naja', 'investigatorAffiliation': 'Makassed General Hospital'}}}}