Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT01217593
Status:
UNKNOWN
Last Update Posted:
2014-03-21
First Post:
2010-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-20', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scores(VAS)for pain and perioperative opioid requirements', 'timeFrame': '24 hours', 'description': 'The VAS scores and the opioid consumption will be compared between the ultrasound group and the predetermined distance technique group.'}], 'secondaryOutcomes': [{'measure': 'time, incidence of adverse events and patient satisfaction', 'timeFrame': '24 hours', 'description': 'The secondary objectives will be 1) time taken to locate the paravertebral space and inject local anesthetic 2) time from injection of local anesthetic to adequate sensory block 3) incidence of adverse events including pneumothorax, high spinal, epidural spread, direct nerve damage, paresthesias, vascular puncture, patient discomfort, respiratory depression, hypoxemia, and prolonged sensory blockade and 4) patient satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mastectomy', 'breast cancer', 'breast surgery'], 'conditions': ['Mastectomy', 'Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '708565', 'type': 'BACKGROUND', 'citation': 'la Grange P, Foster PA, Pretorius LK. Application of the Doppler ultrasound bloodflow detector in supraclavicular brachial plexus block. Br J Anaesth. 1978 Sep;50(9):965-7. doi: 10.1093/bja/50.9.965.'}, {'pmid': '9322469', 'type': 'RESULT', 'citation': 'Marhofer P, Schrogendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7. doi: 10.1097/00000539-199710000-00026.'}, {'pmid': '17456685', 'type': 'RESULT', 'citation': 'Domingo-Triado V, Selfa S, Martinez F, Sanchez-Contreras D, Reche M, Tecles J, Crespo MT, Palanca JM, Moro B. Ultrasound guidance for lateral midfemoral sciatic nerve block: a prospective, comparative, randomized study. Anesth Analg. 2007 May;104(5):1270-4, tables of contents. doi: 10.1213/01.ane.0000221469.24319.49.'}, {'pmid': '15923270', 'type': 'RESULT', 'citation': 'Willschke H, Marhofer P, Bosenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 Aug;95(2):226-30. doi: 10.1093/bja/aei157. Epub 2005 May 27.'}, {'pmid': '17449890', 'type': 'RESULT', 'citation': 'Oberndorfer U, Marhofer P, Bosenberg A, Willschke H, Felfernig M, Weintraud M, Kapral S, Kettner SC. Ultrasonographic guidance for sciatic and femoral nerve blocks in children. Br J Anaesth. 2007 Jun;98(6):797-801. doi: 10.1093/bja/aem092. Epub 2007 Apr 21.'}, {'pmid': '19776028', 'type': 'RESULT', 'citation': 'Deegan CA, Murray D, Doran P, Ecimovic P, Moriarty DC, Buggy DJ. Effect of anaesthetic technique on oestrogen receptor-negative breast cancer cell function in vitro. Br J Anaesth. 2009 Nov;103(5):685-90. doi: 10.1093/bja/aep261. Epub 2009 Sep 22.'}, {'pmid': '19427625', 'type': 'RESULT', 'citation': 'Boughey JC, Goravanchi F, Parris RN, Kee SS, Kowalski AM, Frenzel JC, Bedrosian I, Meric-Bernstam F, Hunt KK, Ames FC, Kuerer HM, Lucci A. Prospective randomized trial of paravertebral block for patients undergoing breast cancer surgery. Am J Surg. 2009 Nov;198(5):720-5. doi: 10.1016/j.amjsurg.2008.11.043. Epub 2009 May 9.'}, {'pmid': '17473369', 'type': 'RESULT', 'citation': 'Goldfarb Y, Ben-Eliyahu S. Surgery as a risk factor for breast cancer recurrence and metastasis: mediating mechanisms and clinical prophylactic approaches. Breast Dis. 2006-2007;26:99-114. doi: 10.3233/bd-2007-26109.'}, {'pmid': '9563536', 'type': 'RESULT', 'citation': 'Coveney E, Weltz CR, Greengrass R, Iglehart JD, Leight GS, Steele SM, Lyerly HK. Use of paravertebral block anesthesia in the surgical management of breast cancer: experience in 156 cases. Ann Surg. 1998 Apr;227(4):496-501. doi: 10.1097/00000658-199804000-00008.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ultrasound and predetermined distance techniques for finding the paravertebral space to inject the local anesthetic (numbing medicine) when you are given anesthesia for surgery. The paravertebral space is located on either side of the spinal cord and contains the nerves that provide sensation to the chest wall. The predetermined distance technique is a series of measurements taken to determine the location of the paravertebral space where the local anesthetic is injected. The ultrasound technique uses direct visualization of the local anesthetic being placed in the paravertebral space. This type of anesthesia has many benefits including decreasing your pain after breast surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females age 25 - 85\n* ASA Physical status I-III\n* Scheduled for primary mastectomy\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Allergy to:\n\nLocal anesthetics Fentanyl Hydromorphone Propofol Midazolam\n\n* Patient refusal\n* Infection at the injection site\n* Peripheral Neuropathy\n* Bilateral breast surgery\n* Prior thoracic surgery on surgical side\n* Severe spinal deformity\n* Coagulopathy'}, 'identificationModule': {'nctId': 'NCT01217593', 'briefTitle': 'Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'A Comparison Of Ultrasound and Predetermined Distance Techniques For Paravertebral Space Localization In Breast Surgery: A Randomized Prospective Trial', 'orgStudyIdInfo': {'id': '2010.116.C'}, 'secondaryIdInfos': [{'id': 'PI-Osteen', 'type': 'OTHER', 'domain': 'Ochnser Clinic Foundation Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultrasound', 'description': 'Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.', 'interventionNames': ['Procedure: ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'predetermined distance', 'description': 'The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.', 'interventionNames': ['Procedure: predetermined distance']}], 'interventions': [{'name': 'ultrasound', 'type': 'PROCEDURE', 'description': 'Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.', 'armGroupLabels': ['ultrasound']}, {'name': 'predetermined distance', 'type': 'PROCEDURE', 'description': 'The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.', 'armGroupLabels': ['predetermined distance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristie Osteen, MD', 'role': 'CONTACT', 'email': 'kosteen@ochsner.org', 'phone': '504-842-3755'}, {'name': 'Heather Porter, BA', 'role': 'CONTACT', 'email': 'hporter@ochsner.org', 'phone': '504-842-4812'}], 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Kristie Osteen, MD', 'role': 'CONTACT', 'email': 'kosteen@ochsner.org', 'phone': '504-842-3755'}, {'name': 'Heather S Porter, BA', 'role': 'CONTACT', 'email': 'hporter@ochsner.org', 'phone': '504-842-4812'}], 'overallOfficials': [{'name': 'Kristie Osteen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ochsner Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Perioperative Anesthesia', 'investigatorFullName': 'Kristie Osteen', 'investigatorAffiliation': 'Ochsner Health System'}}}}