Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT03942003
Status:
UNKNOWN
Last Update Posted:
2021-07-12
First Post:
2019-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effects of Rhomboid Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative analgesic consumption', 'timeFrame': 'at first 24 hour of postoperative period', 'description': 'Postoperative analgesic needs of patients will be recorded in the patient-controlled analgesia device. Postoperative pain, digital evaluation scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) of all patients will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Sleep quality: NRS', 'timeFrame': 'at first morning after operation day', 'description': 'The postoperative first night sleep quality of the patients will be recorded with NRS (0 = not sleeping all night, 10 = very good sleep).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Breast surgery is a common surgical procedure because of the prevalence of breast cancer. Postoperative analgesia management in breast surgery is difficult due to the content of the surgical procedure and the complex innervation of the breast. Multimodal approach is recommended for postoperative analgesia. Therefore, various methods are used. There was no comparison of these two blocks to control group in the literature. In this study, the investigators planned to investigate the postoperative pain, analgesic usage dose and side effects of patients undergoing breast surgery under general anesthesia with a rhomboid area block, pectoral area block.', 'detailedDescription': 'Regional methods and pharmacological treatments are among these methods. The blocks of serratus, pectoral and rhomboid from the regional blocks are used more safely and with increasing frequency, especially with the introduction of ultrasonography in the clinic. In 2016, the rhomboid intercostal nerve block was identified and presented in the literature as a case report. In the rhomboid block, the analgesia created by the local anesthetic on the anterior thoracic wall was used. For patients who will undergo elective breast surgery, the routine routinely applied in our clinic is a multimodal approach, which involves conducting a peripheral nerve block following general anesthesia induction for postoperative analgesia. All patients before the block are standardized and intravenous vascular access is opened. In our clinic, all peripheral blocks are performed under sterile conditions accompanied by ultrasound and stimulator. When applying the Rhomboid nerve block, the patient is tilted to the side position so that the corresponding breast is at the top. After T7 up to T10 sterile preparation of the C7 spinous projection, the convex probe shows a rhomboid muscle at the level of T5 and block is applied with 0.25% bupivacaine (20 cc), 2% lidocaine (10 cc) and 10 cc SF mixture. The PEC I field block is performed by administering 10 cc of local anesthetic between the pectoralis minor and the major at the 2nd costal position. PEC II field block is performed using linear USG probe visibly in 3rd and 4th ribs while the patient is in supine position. In this block, a total of 20 cc 0.25% bupivacaine (10 cc), 2% lidocaine (5 cc) and 5 cc SF mixture were used to block the area between the pectoralis minor muscle and the serratus muscle. Sensory block is evaluated with cold stimulus (0 = no cold sensation, 1 = cold feeling severely decreased, 2 = cold feeling slightly reduced, 3 = normal cold feeling). Patients undergoing breast surgery routinely undergo general anesthesia with propofol 2-3 mg / kg, fentanyl 1mcq / kg, lidocaine 1 mg / kg and rocuronium 0.6 mg / kg. The postoperative analgesic needs of the patients will be recorded in the patient-controlled analgesia device. Postoperative pain, digital evaluation scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) of all patients will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mastectomy\n* general anesthesia\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Chronic analgesic treatment\n* cardiovascular disease\n* non-cooperative patients'}, 'identificationModule': {'nctId': 'NCT03942003', 'briefTitle': 'Analgesic Effects of Rhomboid Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Diskapi Yildirim Beyazit Education and Research Hospital'}, 'officialTitle': 'Investigation of the Analgesic Effects of the Rhomboid Intercostal Block and Pectoral Nerve Block Applied in Breast Surgery', 'orgStudyIdInfo': {'id': 'Rhomboid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rhomboid', 'description': 'When applying the Rhomboid nerve block, the patient is tilted to the side position so that the corresponding breast is at the top. After T7 up to T10 sterile preparation of the C7 spinous projection, the convex probe shows a rhomboid muscle at the level of T5 and block is applied with 0.25% bupivacaine (20 cc), 2% lidocaine (10 cc) and 10 cc SF mixture.', 'interventionNames': ['Procedure: rhomboid blocks']}, {'type': 'EXPERIMENTAL', 'label': 'Pectoral', 'description': 'The PEC I field block is performed by administering 10 cc of local anesthetic between the pectoralis minor and the major at the 2nd costal position. PEC II field block is performed using linear USG probe visibly in 3rd and 4th ribs while the patient is in supine position. In this block, a total of 20 cc 0.25% bupivacaine (10 cc), 2% lidocaine (5 cc) and 5 cc SF mixture were used to block the area between the pectoralis minor muscle and the serratus muscle', 'interventionNames': ['Procedure: PEC blocks']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Infiltration analgesia was performed.', 'interventionNames': ['Procedure: Control groups']}], 'interventions': [{'name': 'rhomboid blocks', 'type': 'PROCEDURE', 'description': 'Rhomboid nerve block was performed', 'armGroupLabels': ['Rhomboid']}, {'name': 'PEC blocks', 'type': 'PROCEDURE', 'description': 'PEC I-II blocks was performed', 'armGroupLabels': ['Pectoral']}, {'name': 'Control groups', 'type': 'PROCEDURE', 'description': 'Infiltration analgesia was performed', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'SAVAS ALTINSOY', 'role': 'CONTACT', 'email': 'savasaltinsoy@gmail.com', 'phone': '+903125962553'}], 'facility': 'University of Health Siences Diskapi Yildirim Beyazit T&R hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Savaş Altınsoy', 'role': 'CONTACT', 'email': 'savasaltinsoy@gmail.com', 'phone': '+903125962553'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Savas Altinsoy', 'investigatorAffiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}}}}