Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-04-23 @ 1:56 PM
Study NCT ID:
NCT02671851
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2016-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D004177', 'term': 'Dipyrone'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000632', 'term': 'Aminopyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-09', 'studyFirstSubmitDate': '2016-01-22', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first pain', 'timeFrame': '0-48 hours', 'description': 'Postoperative first pain description NRS ≥4'}], 'secondaryOutcomes': [{'measure': 'Fentanyl use', 'timeFrame': 'During the surgery', 'description': 'Intraoperative fentanyl was used if heart rate or mean arterial pressure increased \\>20% above preinduction values'}, {'measure': 'Tramadol use', 'timeFrame': '0-2 hours', 'description': 'Postoperative pain NRS ≥4 in the postoperative care unit'}, {'measure': 'Rescue analgesic requirement', 'timeFrame': '0-48 hours', 'description': 'Postoperative pain NRS ≥4 on the wards'}, {'measure': 'Length of stay in the PACU', 'timeFrame': '0-2 hours', 'description': "White's Fast-Tracking Scoring System ≥12 was used for PACU discharge with no score of \\<1 in any category"}, {'measure': 'Pain (NRS) scores', 'timeFrame': '0-48 hours', 'description': 'Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)'}, {'measure': 'Incidence of Postoperative nausea and vomiting (PONV)', 'timeFrame': '0-48 hours', 'description': 'Incidence of PONV'}, {'measure': 'Patient satisfaction (Satisfaction scores)', 'timeFrame': '0-48 hours', 'description': 'Satisfaction scores (0: very unsatisfied, 3: very satisfied)'}, {'measure': 'Surgeon satisfaction (Satisfaction scores)', 'timeFrame': '0-48 hours', 'description': 'Satisfaction scores (0: very unsatisfied, 3: very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thoracic Paravertebral Blocks', 'Ultrasound Guidance', 'Reduction Mammoplasty', 'Time to First Pain', 'Postoperative Analgesia'], 'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '22055006', 'type': 'RESULT', 'citation': 'Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.'}, {'pmid': '17023279', 'type': 'RESULT', 'citation': 'Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.'}, {'pmid': '18042892', 'type': 'RESULT', 'citation': 'Moller JF, Nikolajsen L, Rodt SA, Ronning H, Carlsson PS. Thoracic paravertebral block for breast cancer surgery: a randomized double-blind study. Anesth Analg. 2007 Dec;105(6):1848-51, table of contents. doi: 10.1213/01.ane.0000286135.21333.fd.'}, {'pmid': '11812698', 'type': 'RESULT', 'citation': 'Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents. doi: 10.1097/00000539-200202000-00023.'}, {'pmid': '10825328', 'type': 'RESULT', 'citation': 'Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.'}]}, 'descriptionModule': {'briefSummary': 'Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.\n\nObjective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.\n\nDesign: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.\n\nIntervention: Thirty patients, received only GA, were included in Group GA. Thirty-four patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased \\>20% above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards (NRS≥4).\n\nMain outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.', 'detailedDescription': 'Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.\n\nObjective: The objective was to assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.\n\nDesign: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammaplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.\n\nIntervention: Standard monitoring was applied before any anesthetic techniques were performed. All patients were given sedation in the form of midazolam 1-2 mg and fentanyl 50-100 µg. Patients underwent bilateral reduction mammaplasty were distributed to two groups due to their data: 1) Patients received only general anaesthesia (GA) were included in Group GA, and 2) Patients received preoperative US-guided TPVBs as an adjunct to GA were included in Group TPVBs. Thirty patients were in Group GA. Thirty-four patients who were in Group TPVBs received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% (20 mL per injection) at the level of T3-4, as an adjunct to GA. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased \\>20% above pre-induction values. They also received postoperative tramadol 1mg/kg in the postoperative care unit (PACU) and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards, if numeric rating scale (NRS) was ≥4.\n\nMain outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients undergoing bilateral reduction mammoplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III patients who underwent bilateral reduction mammoplasty\n\nExclusion Criteria:\n\n* Patients with deficient data'}, 'identificationModule': {'nctId': 'NCT02671851', 'briefTitle': 'Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anaesthesia in Patients Undergoing Reduction Mammoplasty: A Historical Cohort Study', 'orgStudyIdInfo': {'id': '2016/83'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thoracic paravertebral blocks (TPVBs)', 'description': 'Patients received bilateral single injection ultrasound-guided TPVBs at the level of T3-T4 with 20 mL bupivacaine 0.375% as an adjunct to general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics.', 'interventionNames': ['Drug: Thoracic paravertebral blocks (TPVBs)']}, {'label': 'IV metamizole sodium, paracetamol', 'description': 'Patients received only standardized general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics.', 'interventionNames': ['Drug: IV metamizole sodium, paracetamol']}], 'interventions': [{'name': 'Thoracic paravertebral blocks (TPVBs)', 'type': 'DRUG', 'otherNames': ['Bupivacaine,fentanyl,tramadol,metamizole sodium,paracetamol'], 'description': 'Patients received bilateral single injection ultrasound-guided TPVBs with 20mL bupivacaine 0.375% at the level of T3-T4 as an adjunct to GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.', 'armGroupLabels': ['Thoracic paravertebral blocks (TPVBs)']}, {'name': 'IV metamizole sodium, paracetamol', 'type': 'DRUG', 'otherNames': ['Fentanyl,tramadol,metamizole sodium,paracetamol'], 'description': 'Patients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.', 'armGroupLabels': ['IV metamizole sodium, paracetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Department of Anaesthesiology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Emine A Salviz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Design and conduct the study, review and analyze the data, and write the manuscript'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Attending Anesthesiologist', 'investigatorFullName': 'Emine Aysu Salviz, MD', 'investigatorAffiliation': 'Istanbul University'}}}}