Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT03650335
Status:
UNKNOWN
Last Update Posted:
2019-02-01
First Post:
2018-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bupivacaine in Ultrasound-guided Erector Spinae Plane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2018-08-25', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative opioid consumption', 'timeFrame': 'First 24 hours total opioid consumption', 'description': 'Total opioid consumption as microgram/kg will be assessed in 24 hour surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spine plan block', 'postoperative opioid consumption', 'thoracotomy', 'analgesia', 'anesthesia'], 'conditions': ['Thoracotomy']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of two different volumes of bupivacaine 0.25% used in ultrasound-guided erector spinae plane (ESP) block on dermatome spread and postoperative analgesia in patients undergoing unilateral thoracotomy', 'detailedDescription': 'The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 50 patients planned for thoracotomy, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 25 patients each. Patients that will be transferred to the intensive care unit (ICU) intubated after the surgery, patients with a body mass index of 35 or over, patients detected with infection in the intervention site, patients with hematological diseases, patients with a known allergy to local anesthetics, patients that will not provide a written or verbal consent, pregnant patients, and patients with an ASA score of III or IV will be excluded from the study. All the patients will undergo physical examination and their laboratory parameters will be evaluated one day prior to the procedure. Moreover, on the same day, each patient will be informed about dermatome testing (hot/cold), pain prick test (pain test), and pain pump set. Age, body height and weight, duration of block, and duration of surgery will be recorded for each patient'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing thoracotomy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective thoracotomy\n* Aged 18-65 years\n* ASA score of I and II\n\nExclusion Criteria:\n\n* Patients that will be transferred to the intensive care unit (ICU) intubated after the surgery,\n* Patients with a body mass index of 35 or over,\n* Patients detected with infection in the intervention site,\n* Patients with hematological diseases,\n* Patients with a known allergy to local anesthetics,\n* Patients that will not provide a written or verbal consent,\n* Pregnant patients\n* Patients with an ASA score of III or IV will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT03650335', 'briefTitle': 'Effect of Bupivacaine in Ultrasound-guided Erector Spinae Plane', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Effect of Two Different Volumes of Bupivacaine 0.25% Used in Ultrasound-guided Erector Spinae Plane (ESP) Block on Dermatome Spread: A Volume Study', 'orgStudyIdInfo': {'id': 'ESP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group I', 'description': 'with a total of 20 mL 0.25% bupivacaine injection to be administered'}, {'label': 'group II', 'description': 'with a total of 30 mL 0.25% bupivacaine injection to be administered'}]}, 'contactsLocationsModule': {'locations': [{'zip': '65080', 'city': 'Van', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Celaleddin soyalp', 'role': 'CONTACT', 'email': 'c.soyalp@hotmail.com', 'phone': '+905068456504'}, {'name': 'Nureddin Yuzkat', 'role': 'CONTACT', 'email': 'nyuzkat@gmail.com', 'phone': '+905052294728'}], 'facility': 'Celaleddin Soyalp', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'centralContacts': [{'name': 'Celaleddin Soyalp', 'role': 'CONTACT', 'email': 'c.soyalp@hotmail.com', 'phone': '+905068456504'}, {'name': 'Nureddin Yuzkat', 'role': 'CONTACT', 'email': 'nyuzkat@gmail.com', 'phone': '+905052294728'}], 'overallOfficials': [{'name': 'celaleddin soyalp', 'role': 'STUDY_CHAIR', 'affiliation': 'Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology and Reanimation Department Van, Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist .Prof.', 'investigatorFullName': 'Celaleddin Soyalp', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}