Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT04259502
Status:
UNKNOWN
Last Update Posted:
2020-02-06
First Post:
2020-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rhomboid Intercostal Block vs Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The two interventions will be performed at the same thoracic region using the same technique as so; there participant will be blinded to the study. The investigator who performs the intervention will be unblinded. The investigator who will follow up the patients and collect the postoperative pain data will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients included in the study will be assigned to one group of two in which two different regional block technique will be performed alone.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Throughout post-operative course, up to 48 hours', 'description': 'Subjective pain score reported by the patient, assessed by a blinded investigator to the study; which is defined as the score in a scale between minimum value of zero and maximum value of 10 (higher scores mean a better outcome).'}, {'measure': 'Peroperative Analgesia', 'timeFrame': 'At the end of the operation', 'description': 'Fentanyl consumption'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': '48th postoperative hour', 'description': 'Total tramadol consumption'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative Analgesia', 'Peroperative Analgesia', 'Ultrasound', 'Rhomboid intercostal block', 'Erector spinae plane block', 'Mastectomy'], 'conditions': ['Analgesia', 'Perioperative Analgesia', 'Postoperative Analgesia']}, 'referencesModule': {'references': [{'pmid': '27291611', 'type': 'BACKGROUND', 'citation': 'Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.'}, {'pmid': '30851500', 'type': 'BACKGROUND', 'citation': 'Balaban O, Aydin T. A modified approach of rhomboid intercostal block for postoperative analgesia in modified radical mastectomy: Ultrasound guided bi-level high thoracic injection. J Clin Anesth. 2019 Nov;57:29-30. doi: 10.1016/j.jclinane.2019.03.002. Epub 2019 Mar 6. No abstract available.'}, {'pmid': '30851503', 'type': 'BACKGROUND', 'citation': 'Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.'}, {'pmid': '30553225', 'type': 'BACKGROUND', 'citation': 'Tulgar S, Selvi O, Thomas DT, Manukyan M, Ozer Z. Rhomboid intercostal block in a modified radical mastectomy and axillary curettage patient; A new indication for novel interfascial block. J Clin Anesth. 2019 May;54:158-159. doi: 10.1016/j.jclinane.2018.12.006. Epub 2018 Dec 13. No abstract available.'}, {'pmid': '30988534', 'type': 'BACKGROUND', 'citation': 'Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18.'}, {'pmid': '31080959', 'type': 'BACKGROUND', 'citation': 'Selvi O, Tulgar S. Use of the Ultrasound-Guided Erector Spinae Plane Block in Segmental Mastectomy. Turk J Anaesthesiol Reanim. 2019 Apr;47(2):158-160. doi: 10.5152/TJAR.2019.50024. Epub 2019 Jan 29.'}, {'pmid': '29980005', 'type': 'BACKGROUND', 'citation': 'Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.'}, {'pmid': '29688930', 'type': 'BACKGROUND', 'citation': 'Kimachi PP, Martins EG, Peng P, Forero M. The Erector Spinae Plane Block Provides Complete Surgical Anesthesia in Breast Surgery: A Case Report. A A Pract. 2018 Oct 1;11(7):186-188. doi: 10.1213/XAA.0000000000000777.'}, {'pmid': '31736025', 'type': 'BACKGROUND', 'citation': 'Aksu C, Kus A, Yorukoglu HU, Tor Kilic C, Gurkan Y. Analgesic effect of the bi-level injection erector spinae plane block after breast surgery: A randomized controlled trial. Agri. 2019 Jul;31(3):132-137. doi: 10.14744/agri.2019.61687.'}, {'pmid': '30396100', 'type': 'BACKGROUND', 'citation': 'Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.'}, {'pmid': '31280100', 'type': 'BACKGROUND', 'citation': 'Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'Effectiveness of erector spinae plane block for analgesia in breast surgery was documented in previous studies. Rhomboid intercostal block may be beneficial for analgesia in breast surgery. The aim of this study is to compare the peri-operative analgesic effect of rhomboid intercostal block with erector spinae plane block in mastectomy operation. This trial was designed as prospective randomized single-blind study. The included patients will be assigned into two groups: RIB-Group where the patients will receive ultrasound-guided rhomboid intercostal block and ESP-Group where the patients will receive ultrasound-guided erector spinae plane block prior to the operation. Primary outcome will be peri-operative pain scores and secondary outcomes will be peri-operative opioid consumption and peri-operative hemodynamic effect of these blocks.', 'detailedDescription': 'Postoperative analgesia in breast surgery is important in reducing morbidity and mortality. Intravenous or oral analgesics may be used for this purpose. Ultrasound-guided fascia plane blocks are used to provide effective analgesia in mastectomy operations. Effectiveness of erector spinae plane block for analgesia in breast surgery was documented in previous studies.\n\nRhomboid intercostal block may be beneficial for analgesia in breast surgery. Both blocks have the advantage of unilateral application in unilateral mastectomy operations. When administered pre-operatively, it also provides per-operative analgesia and may reduce per-operative opioid consumption. These blocks are applied under ultrasound-guidance with single injection. Since the site of injection is relatively superficial (between the back muscles and ribs) and applied under ultrasound-guidance, mechanical complications is expected to occur less. These low-cost blocks also may reduce the usage of high-cost and high-risk opioids after surgery. These blocks unilaterally anesthetize the nerves innervating the thoracic region and the axilla, thus providing effective per-operative and post-operative analgesia in mastectomy operations.\n\nThe aim of our study is to compare the rhomboid intercostal block with erector spina plane block in mastectomy in terms of intraoperative and postoperative analgesia in mastectomy operation. Our hypothesis is rhomboid intercostal block may reduce peri-operative pain as effective as or more effectively than erector spina plane block. Secondary hypothesis is rhomboid intercostal block may reduce peri-operative opioid consumption as effective as or more effectively than erector spina plane block. Thus, the study is defined as block technique comparison.\n\nEighty patients aged between 29-79 years who are planned mastectomy under general anesthesia will be included in the study. Patients with severe cardiac and respiratory disease, severe coagulation disorder, body mass index greater than 35, refusal of regional block and patients having local infection in block application area, contraindication of the standardized drugs in the study and patients with insufficient postoperative analgesia requiring more potent opioids will be excluded from the study.\n\nThe patients who meet the study criteria will be assigned into two groups by using computerized randomization. Patients who do not give consent will also be excluded from the study. All patients will be sedated with midazolam and fentanyl prior to block application. First group (RIB-Group) of patients will receive ultrasound-guided rhomboid intercostal block prior to the operation under sedation. Patients in the second group (ESP-Group) will receive ultrasound-guided erector spina plane block under sedation. Since both procedures will be performed from the same site, the study was considered as a single blind.\n\nAll patients will be intubated after induction of general anesthesia with Propofol 2 mg / kg, Rocuronium 0.6 mg / kg and Fentanyl 1.5 µg / kg. Mixture of Desflurane 6% concentration in 50% air and 50% oxygen will be used for the maintenance of general anesthesia. Patients in both groups will receive 1 µg / kg of fentanyl when pain occurs during surgery. Pre-operative and post-operative blood pressure, heart rate, oxygen saturation, end-tidal carbon dioxide values of patients in both groups will be measured and recorded at determined time intervals.\n\nPatients will be followed for 48 hours after the operation. In the postoperative period, acetaminophen 1 g three times a day will be administered routinely in context of multimodal analgesia. Intravenous tramadol 1 mg/kg will also be administered depending on patient need up to 4 times a day. Total amount of perioperative opioids will be recorded. Per-operative and post-operative opioid consumption will be calculated separately. Pain assessment will be evaluated by using a verbal analog scale (asking patients to give a pain score between 0 and 10. Score of 0 means worse pain ever and score of 10 means no pain). Complications related to the block procedure will be also recorded. If there is pain that requires more potent opioids such as morphine, the block will be considered as unsuccessful.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '29 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are planned mastectomy under general anesthesia\n\nExclusion Criteria:\n\n* Patients with severe cardiac and respiratory disease\n* Severe coagulation disorder\n* Body mass index greater than 35 kg/m2\n* Refusal of regional block\n* Patients having local infection in block application area\n* Contraindication of the standardized drugs in the study\n* Insufficient postoperative analgesia requiring more potent opioids'}, 'identificationModule': {'nctId': 'NCT04259502', 'briefTitle': 'Rhomboid Intercostal Block vs Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Comparison of Rhomboid Intercostal Block and Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy', 'orgStudyIdInfo': {'id': '2019/06RIBVSESP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIB Group', 'description': 'A single injection Rhomboid intercostal block will be performed under ultrasound guidance', 'interventionNames': ['Procedure: Rhomboid intercostal block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESP Group', 'description': 'A single injection Erector spinae plane block will be performed under ultrasound guidance', 'interventionNames': ['Procedure: Erector spinae plane block']}], 'interventions': [{'name': 'Rhomboid intercostal block', 'type': 'PROCEDURE', 'description': 'The block is regional anesthesia injection techniques performed under ultrasound guidance.', 'armGroupLabels': ['RIB Group']}, {'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'The block is regional anesthesia injection techniques performed under ultrasound guidance.', 'armGroupLabels': ['ESP Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43040', 'city': 'Kütahya', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Onur Balaban, MD.', 'role': 'CONTACT', 'email': 'obalabandr@gmail.com', 'phone': '+90 274 231 6660'}, {'name': 'Tayfun Aydın, MD.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Buse Kozlu, MD.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Miray K Turgut, MD.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kutahya Health Sciences University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}], 'centralContacts': [{'name': 'Onur Balaban, MD.', 'role': 'CONTACT', 'email': 'obalabandr@gmail.com', 'phone': '+90 274 231 6660'}], 'overallOfficials': [{'name': 'Onur Balaban, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kutahya Health Sciences University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asistan Professor, MD.', 'investigatorFullName': 'Onur Balaban, MD', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}