Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-27 @ 2:17 AM
Study NCT ID:
NCT02871193
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2016-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2016-07-17', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy', 'timeFrame': '6 hours,12hours,24hours and 72hours after operation', 'description': 'to show the grading of pain in different groups after surgery'}, {'measure': 'the reality pressing number of patient controlled analgesia(PCA) of patients with different treatment-related events in the following 3 days after surgery', 'timeFrame': '6hours,12hours,24hours and 72hours after operation', 'description': 'to show the consumption of analgesics after surgery'}], 'secondaryOutcomes': [{'measure': 'hemodynamic index', 'timeFrame': '24 hours after anesthesia', 'description': 'To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.'}, {'measure': 'The time of recovery', 'timeFrame': '24 hours after surgery', 'description': 'to show the quality of recovery'}, {'measure': 'The time of extubation', 'timeFrame': '24 hours after surgery', 'description': 'to show the quality of recovery'}, {'measure': 'the incidence of side effects', 'timeFrame': '3days after operation', 'description': 'To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation.'}, {'measure': 'The complication after surgery', 'timeFrame': '30 days after surgery', 'description': 'To compare the incidence rates of complications, such as pneumonia, atelectasis, respiratory failure, heart failure, etc'}, {'measure': 'The first day of leaving bed after surgery', 'timeFrame': '30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['paravertebral block', 'patient controlled analgesia', 'ropivacaine', 'dexamethasone'], 'conditions': ['Surgery']}, 'referencesModule': {'references': [{'pmid': '20599397', 'type': 'RESULT', 'citation': 'Carmona P, Llagunes J, Canovas S, de Andres J, Marques I. The role of continuous thoracic paravertebral block for fast-track anesthesia after cardiac surgery via thoracotomy. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):205-6. doi: 10.1053/j.jvca.2010.04.005. No abstract available.'}, {'pmid': '26938764', 'type': 'RESULT', 'citation': 'Tomar GS, Ganguly S, Cherian G. Effect of Perineural Dexamethasone With Bupivacaine in Single Space Paravertebral Block for Postoperative Analgesia in Elective Nephrectomy Cases: A Double-Blind Placebo-Controlled Trial. Am J Ther. 2017 Nov/Dec;24(6):e713-e717. doi: 10.1097/MJT.0000000000000405.'}, {'pmid': '24448512', 'type': 'RESULT', 'citation': 'Ilfeld BM, Madison SJ, Suresh PJ, Sandhu NS, Kormylo NJ, Malhotra N, Loland VJ, Wallace MS, Proudfoot JA, Morgan AC, Wen CH, Wallace AM. Treatment of postmastectomy pain with ambulatory continuous paravertebral nerve blocks: a randomized, triple-masked, placebo-controlled study. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):89-96. doi: 10.1097/AAP.0000000000000035.'}, {'pmid': '26612450', 'type': 'RESULT', 'citation': 'Ke JD, Hou HJ, Wang M, Zhang YJ. The comparison of anesthesia effect of lung surgery through video-assisted thoracic surgery: A meta-analysis. J Cancer Res Ther. 2015 Nov;11 Suppl:C265-70. doi: 10.4103/0973-1482.170534.'}, {'pmid': '25123271', 'type': 'RESULT', 'citation': 'Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'The procedures of thoracotomy are among the most painful operations. In addition to post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient and prevent postoperative complications such as pneumonia, atelectasis, or respiratory failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an alternative technique for TEA that may offer a comparable analgesic effect and a better side -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as single injection, they can provide analgesia for limited period. Various adjuvants have been tried in the past in order to enhance the duration and quality of postoperative analgesia. Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of local anesthetic block. The mechanism of its action is blocking the nociceptive impulse transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration. System of wire-less PCA provides remote monitoring, information management and PCA devices with high precision. The purpose of this research is to determine whether dexamethasone might prolong the duration of analgesia and improve the short-time outcomes when administered for TPVB along with local anesthetic agents in elective thoracotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. patient American Society of Anesthesiologists（ASA） I\\~III undergoing elective thoracotomy\n2. written informed consent from the patient or the relatives of the participating patient\n\nExclusion Criteria:\n\n1. mental illness\n2. thoracic paravertebral blocks contraindicated\n3. local anesthetic allergy\n4. people who have heart disease\n5. people who have severe liver or renal disease\n6. people who have severe endocrine disease\n7. people who can't communicate effectively because of hearing or visual disorders"}, 'identificationModule': {'nctId': 'NCT02871193', 'briefTitle': 'Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Anhui Medical University'}, 'officialTitle': 'Study of Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy', 'orgStudyIdInfo': {'id': 'Kuai2016-06-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Group C（Control）', 'description': 'Group C received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml combined with general anesthesia and intravenous patient controlled analgesia pump.', 'interventionNames': ['Other: saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group R(Ropivacaine)', 'description': 'Group R received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20 ml combined with general anesthesia and intravenous patient controlled analgesia pump.', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D(Dexamethasone)', 'description': 'Group D received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg combined with general anesthesia and intravenous patient controlled analgesia pump.', 'interventionNames': ['Drug: Ropivacaine', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['ropivacaine hydrochloride'], 'description': 'ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml', 'armGroupLabels': ['Group D(Dexamethasone)', 'Group R(Ropivacaine)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['dxm', 'dex'], 'description': 'ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg', 'armGroupLabels': ['Group D(Dexamethasone)']}, {'name': 'saline', 'type': 'OTHER', 'otherNames': ['normal saline'], 'description': 'ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml', 'armGroupLabels': ['Group C（Control）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The first affiliated hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}