Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT03242668
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2017-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-23', 'releaseDate': '2017-09-24'}, {'releaseDate': '2017-10-31', 'unreleaseDateUnknown': True}, {'resetDate': '2018-11-20', 'releaseDate': '2018-04-30'}], 'estimatedResultsFirstSubmitDate': '2017-09-24'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020775', 'term': 'Thoracic Surgery, Video-Assisted'}, {'id': 'D010323', 'term': 'Passive Cutaneous Anaphylaxis'}, {'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D013906', 'term': 'Thoracoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D020535', 'term': 'Video-Assisted Surgery'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000937', 'term': 'Antigen-Antibody Reactions'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '30 patients, with American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery , were enrolled in this randomised observer blinded prospective clinical study. Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more, allergy to any of the study drugs, patients having any contraindication for paravertebral block, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease were excluded from this study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-08-03', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side effects and complications', 'timeFrame': 'three postoperative consecutive days', 'description': 'Respiratory depression (respiratory rate \\< 8 breaths/min), ,confusion, sedation, urinary retention, nausea, vomiting, headache and pruritus was evaluated.'}, {'measure': 'Heart rate', 'timeFrame': 'three postoperative consecutive days', 'description': 'Using monitoring (Philips)'}, {'measure': 'Blood pressure', 'timeFrame': 'three postoperative consecutive days', 'description': 'Using monitoring (Philips)'}], 'primaryOutcomes': [{'measure': 'VAS score at rest and on coughing', 'timeFrame': '72 hours', 'description': 'Using VAS scale (Atrazennica)'}], 'secondaryOutcomes': [{'measure': 'Analgesia effects on respiratory function', 'timeFrame': 'three postoperative consecutive days', 'description': 'Using Spirometry (Chestgraph H1 - 105,Japane) to evaluate respiratory index'}, {'measure': 'Arterial blood gas values', 'timeFrame': 'three postoperative consecutive days', 'description': 'Using Arterial blood gas analysis (STAT Model No.MCP9819-065, Martel Instruments Ltd)'}, {'measure': 'The number dermatome inhibition', 'timeFrame': 'three postoperative consecutive days', 'description': 'Using pin-prick test'}, {'measure': 'Rescue analgesia', 'timeFrame': 'three postoperative consecutive days', 'description': 'When VAS score equal to or more than 4 using fentanyl to manage pain'}, {'measure': "Patient's satisfaction", 'timeFrame': 'three postoperative consecutive days', 'description': 'Using questionaire with 4 levels :not good,satisfied,good,very good'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['paravertebral block,PVC,PCA'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.', 'detailedDescription': 'The study was carried out on thirty patients who underwent video-assisted thoracic surgery.Paravertebral space was identified by loss of resistance technique under video-assisted inside thoracic space before chest close.Initiated dose of 0.3ml/kg of bupivacaine 0.125%+fentanyl 2 mcg/ml was administered then continued patient-controlled analgesia with background rate 3ml/h, bolus dose 2ml, lockout interval 10 minutes. Postoperative pain was accessed by Visual Analogue Scale at rest and on coughing; monitor the heart rate, blood pressure, respiratory rate, SpO2, arterial blood gas and spirometry in three postoperative consecutive days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery.\n\nExclusion Criteria:\n\n* Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more,, allergy to any of the study drugs, patients having any contraindication to placement of PVB, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease.'}, 'identificationModule': {'nctId': 'NCT03242668', 'briefTitle': 'Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Vietnam Military Medical University'}, 'officialTitle': 'Patient Controlled Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': '103HospitalVMMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PVB using PVC for PCA in VATS', 'description': 'The VATS was performed.Paravertebral space was identified by loss of resistance technique combined with video-assisted inside thoracic space before chest close.PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA with background rate 3ml/h, bolus dose 2ml was infused through PVC.', 'interventionNames': ['Procedure: VATS', 'Procedure: PVB using PVC', 'Drug: PCA']}], 'interventions': [{'name': 'VATS', 'type': 'PROCEDURE', 'otherNames': ['Video-Assisted Thoracic Surgery'], 'description': 'General anesthesia was induced with 2.0 mg/kg of propofol, 2.0 mg/kg of fentanyl, and 1.0 mg kg/1 of rocuronium and maintained with continuous infusion 6-12mg/kg/h of propofol,injected 2.0 mg/kg of fentanyl and 0.15 mg/ kg of rocuronium every 30 minutes . All patients were intubated with a double-lumen endobronchial tube for one-lung ventilation.The VATS (Video-Assisted Thoracic Surgery) was performed.', 'armGroupLabels': ['PVB using PVC for PCA in VATS']}, {'name': 'PVB using PVC', 'type': 'PROCEDURE', 'otherNames': ['Paravertebral block using paravertebral catheter'], 'description': 'At the end of the surgery, the upper edge of the spinous process of the thoracic vertebral body was recognized. With an epidural needle (Tuohy 22 G; Braun, Melsungen, Germany), the injection point was punctured 2 cm lateral to the midline. The paravertebral space was entered by advancing the Tuohy needle over the superior border of the transverse process. Once in the right place, the PVC was placed through the needle, checking the tip remained placed when removing the needle. The advance of the needle and the entering of the catheter into the paravertebral space were verified all the time by the surgeon using the camera. The PVC (Paravertebral Catheter ) was inserted at this point preversed at this area.', 'armGroupLabels': ['PVB using PVC for PCA in VATS']}, {'name': 'PCA', 'type': 'DRUG', 'otherNames': ['Patient controlled analgesia'], 'description': 'PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with background rate 3ml/h, bolus dose 2ml was infused through PVC.', 'armGroupLabels': ['PVB using PVC for PCA in VATS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Vietnam Military Medical University', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nguyen Trung Kien', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nguyen Truong Giang, PhD. Associate Prof.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Corresponding author,Clinical Research', 'investigatorFullName': 'Nguyen Trung Kien', 'investigatorAffiliation': 'Vietnam Military Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-09-24', 'type': 'RELEASE'}, {'date': '2017-10-23', 'type': 'RESET'}, {'date': '2017-10-31', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2018-04-30', 'type': 'RELEASE'}, {'date': '2018-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nguyen Trung Kien, Corresponding author,Clinical Research, Vietnam Military Medical University'}}}}