Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT02397603
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2015-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-30', 'studyFirstSubmitDate': '2015-03-15', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of first loading preoperative dose of paravertebral injectate', 'timeFrame': 'One day', 'description': 'Time interval between initiation of the paravertebral block and the time to first rescue analgesia'}], 'secondaryOutcomes': [{'measure': 'Duration of surgery and anesthesia', 'timeFrame': 'Intraoperative period, up to 3-4 hours', 'description': 'Times from start of anesthesia and surgery to the conclusion of surgical intervention'}, {'measure': 'End tidal isoflurane', 'timeFrame': 'Duration of anesthesia, up to 3-4 hours', 'description': 'Average End-tidal isoflurane concentration required to maintain stable hemodynamics'}, {'measure': 'Total intraoperative fentanyl requirements', 'timeFrame': 'Intraoperative period, up to 3-4 hours', 'description': 'The total dose of fentanyl required during the surgical procedure to maintain hemodynamic stability'}, {'measure': 'Total intraoperative ephedrine and atropine requirements', 'timeFrame': 'Intraoperative period, up to 3-4 hours', 'description': 'The total amounts of ephidrine and atropine required for the treatment of possible reduction of arterial blood pressure or heart rate'}, {'measure': 'Total intraoperative crystalloid requirements', 'timeFrame': 'Intraoperative period, up to 3-4 hours', 'description': 'The total volume of intraoperative fluids in ml required to maintain hemodynamic stability'}, {'measure': 'Recovery time', 'timeFrame': 'Immediate postoperative period, up to 2 hour', 'description': 'the time interval between discontinuation of isoflurane and the patient first response to verbal commands'}, {'measure': 'Pain intensities at rest and during coughing as assessed by 0-10 VAS score', 'timeFrame': 'Over 48 hours postoperatively', 'description': 'Pain scores will be assessed using the 11-points visual analogue pain score (VAS) where 0 indicates no pain and 10 indicates the worst pain.'}, {'measure': 'Total doses of bupivacaine, dexmedetomidine, and morphine', 'timeFrame': '48 hours postoperatively', 'description': 'The total doses of three medications will be recorded and compared in the intervention and control groups'}, {'measure': 'Number of paravertebral to-up injections', 'timeFrame': '48 hours postoperatively', 'description': 'The number of to-up doses of bupivacaine required to maintain adequate postoperative analgesia over 48 hours postoperatively'}, {'measure': 'Side effects', 'timeFrame': '48 hours postoperatively', 'description': 'Patients will be monitored for the possible reductions in arterial blood pressure and heart rate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Post-thoracotomy Pain']}, 'referencesModule': {'references': [{'pmid': '23161360', 'type': 'RESULT', 'citation': 'Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral space.', 'detailedDescription': 'Thoracotomy is associated with severe postoperative pain that could be reduced with an aggressive analgesic therapy in the early postoperative period. The use of thoracic paravertebral block is an effective analgesic approach for post-thoracotomy pain. Several local anesthetic adjuvants have been reported to extend the duration of paravertebral block.\n\nAlpha-2 agonists including dexmedetomidine appear to be the most effective in this context. The study will include an intervention group which will receive a combination of 20 ml bupivacaine 0.5% and dexmedetomidine 0.5 ml (50 microgram). The control group will receive 20 ml bupivacaine 0.5% plus 0.5 ml normal saline perineurally. Thoracic paravertebral catheter will be inserted preoperatively. Visual analogue pain score will be assessed at different intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American society of anesthesiologists physical status class \\|\\|or \\|\\|\\|.\n* Patients scheduled for elective thoracotomy.\n\nExclusion Criteria:\n\n* Pneumonectomy, decortication, pleural biopsy.\n* Additional chest wall resection.\n* Emergency surgery.\n* Central and peripheral neuropathies.'}, 'identificationModule': {'nctId': 'NCT02397603', 'briefTitle': 'Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Paravertebral Block in Patients Undergoing Thoracotomy', 'orgStudyIdInfo': {'id': 'N-16-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine saline group', 'description': 'This group of patients will receive 20 ml bupivacaine plus 0.5 ml normal saline perineurally in the paravertebral catheter', 'interventionNames': ['Drug: Bupivacaine saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine- bupivacaine group', 'description': 'This group of patients will receive 20 ml bupivacaine plus 0.5 ml (50 microgram) dexmedetomidine administered perineurally in the paravertebral catheter.', 'interventionNames': ['Drug: dexmedetomidine bupivacaine']}], 'interventions': [{'name': 'dexmedetomidine bupivacaine', 'type': 'DRUG', 'description': 'perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block', 'armGroupLabels': ['Dexmedetomidine- bupivacaine group']}, {'name': 'Bupivacaine saline', 'type': 'DRUG', 'description': 'perineural bupivacaine saline mixture in the thoracic paravertebral catheter', 'armGroupLabels': ['bupivacaine saline group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Kasr Alainy Hospital Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Mohamed Abdulatif, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of anesthesia, surgical intensive care and pain management cairo university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology & Surgical Intensive Care, Faculity of Medicine', 'investigatorFullName': 'Professor Mohamed Abdulatif Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}