Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-02 @ 11:53 AM
Study NCT ID:
NCT03185403
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-12', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-06-12', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of hypotension episodes', 'timeFrame': 'during perioperative until first 24 hours post operative', 'description': 'The frequency of hypotension episodes defined by a mean arterial pressure (MAP) less than 70mmHg or a decrease in MAP greater than 20% when compared with the preoperative value'}], 'secondaryOutcomes': [{'measure': 'Total amount per patient and per group of vasopressins amines', 'timeFrame': 'during perioperative until first 24 hours post operative'}, {'measure': 'Frequency of use of vasopressor agents', 'timeFrame': 'during perioperative until first 24 hours post operative'}, {'measure': 'Volumes of fluid administered', 'timeFrame': 'during perioperative until the first 24h hours post operative'}, {'measure': 'total amount of morphine consumption', 'timeFrame': 'during first 48 hours post operative'}, {'measure': 'visual analog scale', 'timeFrame': 'during first 48 hours post operative, at 3 months and 6 months', 'description': 'Measure the pain severity'}, {'measure': 'DN2 score', 'timeFrame': 'during first 48 hours post operative, at 3 months and 6 months', 'description': 'evaluation with validated scores for chronic and neuropathic pains'}, {'measure': 'Frequency of surgical complications', 'timeFrame': 'during first 48 hours post operative'}, {'measure': 'Frequency of pulmonary complications', 'timeFrame': 'during first 48 hours post operative'}, {'measure': 'total amount and frequency of Post-operative anti-emetic consumption', 'timeFrame': 'during first 48 hours post operative'}, {'measure': 'Death', 'timeFrame': 'up to 28 days postoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemodynamic effect', 'para vertebral block'], 'conditions': ['Epidural Block', 'Oesophageal Cancer', 'Oesophagectomy']}, 'referencesModule': {'references': [{'pmid': '16476698', 'type': 'BACKGROUND', 'citation': 'Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'Continuous Paravertebral block (PVB) was reported to provide less episodes of hypotension than continuous thoracic epidural block (TEB). The maintenance of optimal tissue perfusion is essential for esophageal anastomosis in patients undergoing oesophagectomy. the aim of this study is to compare Hemodynamic effect of continous PVB compared to TEB , in patient undergoing oesophagectomy with laparoscopy and thoracotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA score 1 to 3\n* oesophagectomy : abdominal time with laparoscopy ans thoracic time with thoracotomy\n\nExclusion Criteria:\n\n* pregnancy\n* Uncooperative patient\n* patient refusal\n* Coagulopathy\n* allergy to local anesthetic\n* Psychological Disorders\n* Failure to install the epidural or paravertebral catheter. The patient will therefore be excluded secondarily but will be able to benefit from an alternative technique for the management of his pain.\n* Sepsis\n* Skin infection at the puncture site\n* Allergy to local anesthetics\n* Esophagectomy with cervical surgical time\n* Patient with chronic pain EVA\\> 4 before surgery.'}, 'identificationModule': {'nctId': 'NCT03185403', 'acronym': 'HEMOBLOC', 'briefTitle': 'The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .', 'orgStudyIdInfo': {'id': '2012_47'}, 'secondaryIdInfos': [{'id': '2013-002317-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'continous paravertebral block', 'description': 'echoguided thoracic continous paravertebral block was placed before the surgery.\n\nA bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.', 'interventionNames': ['Other: paravertebral block', 'Drug: ropivacaine', 'Drug: Sufentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'continous Thoracic epidural block', 'description': 'thoracic epidural catheter was inserted before the surgery. A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.', 'interventionNames': ['Other: thoracic epidural block', 'Drug: ropivacaine', 'Drug: Sufentanil']}], 'interventions': [{'name': 'paravertebral block', 'type': 'OTHER', 'description': 'in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level', 'armGroupLabels': ['continous paravertebral block']}, {'name': 'thoracic epidural block', 'type': 'OTHER', 'description': 'in the epidural block the catheter was inserted without echography , at T4/T5 level', 'armGroupLabels': ['continous Thoracic epidural block']}, {'name': 'ropivacaine', 'type': 'DRUG', 'armGroupLabels': ['continous Thoracic epidural block', 'continous paravertebral block']}, {'name': 'Sufentanil', 'type': 'DRUG', 'armGroupLabels': ['continous Thoracic epidural block', 'continous paravertebral block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'CHRU , Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Gilles Lebuffe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}