Ignite Creation Date:
2025-12-17 @ 2:48 PM
Ignite Modification Date:
2025-12-23 @ 10:00 PM
Study NCT ID:
NCT05284695
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2022-02-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The EFFICIENCY of FASCIAL PLANE BLOCKS in BARIATRIC SURGERY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, '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': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-03-08', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative analgesia', 'timeFrame': '0 - 24 hours', 'description': 'Postoperative pain assessment of patients will be made with a numeric rating scale (NRS). Postoperative opioid consumption will be examined'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Regional Anesthesia Morbidity', 'Post Operative Pain', 'Bariatric Surgery Candidate']}, 'referencesModule': {'references': [{'pmid': '31037599', 'type': 'BACKGROUND', 'citation': 'Park CH, Nam SJ, Choi HS, Kim KO, Kim DH, Kim JW, Sohn W, Yoon JH, Jung SH, Hyun YS, Lee HL; Korean Research Group for Endoscopic Management of Metabolic Disorder and Obesity. Comparative Efficacy of Bariatric Surgery in the Treatment of Morbid Obesity and Diabetes Mellitus: a Systematic Review and Network Meta-Analysis. Obes Surg. 2019 Jul;29(7):2180-2190. doi: 10.1007/s11695-019-03831-6.'}, {'pmid': '29077813', 'type': 'BACKGROUND', 'citation': 'Subramani Y, Nagappa M, Wong J, Patra J, Chung F. Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. Br J Anaesth. 2017 Nov 1;119(5):885-899. doi: 10.1093/bja/aex341.'}, {'pmid': '30802933', 'type': 'BACKGROUND', 'citation': 'Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.'}, {'pmid': '28403427', 'type': 'BACKGROUND', 'citation': 'Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.'}, {'pmid': '28085788', 'type': 'BACKGROUND', 'citation': 'Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.'}, {'pmid': '35776242', 'type': 'DERIVED', 'citation': 'Cosarcan SK, Yavuz Y, Dogan AT, Ercelen O. Can Postoperative Pain Be Prevented in Bariatric Surgery? Efficacy and Usability of Fascial Plane Blocks: a Retrospective Clinical Study. Obes Surg. 2022 Sep;32(9):2921-2929. doi: 10.1007/s11695-022-06184-9. Epub 2022 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'Bariatric surgery effectively produces weight loss and reduces obesity-related comorbidities. Although it is mostly performed with minimally invasive techniques, the patients may still suffer from moderate-to-severe pain immediately after surgery \\[1\\]. Opioids remain the first choice for multimodal analgesia in the treatment of postoperative pain. Providing analgesia after bariatric surgery might be challenging due to a high prevalence of obstructive sleep apnea syndrome and the increased sensitivity to respiratory depression triggered by opioid overuse after surgeryThe most common plane block techniques utilized during laparoscopic bariatric surgery are transversus abdominis plane block (TAP), rectus sheath block (RB), the erector spinae plane block (ESPB) and the external oblique intercostal block (EOI). In this study, we have evaluated the auxiliary benefit of these various techniques in reduction of the postoperative in bariatric surgery. patients who had laparoscopic bariatric surgery at VKV American Hospital between January 2019 and December 2021 were reviewed retrospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Fascial plane blocks and postoperative analgesia efficacy were investigated in bariatric surgery patients.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing elective bariatric surgery\n\nExclusion Criteria:\n\n* Patients with a history of cerebrovascular events\n* Alzheimer's and dementia\n* inadequate cognitive functions\n* history of chronic pain\n* long-term opioid therapy"}, 'identificationModule': {'nctId': 'NCT05284695', 'briefTitle': 'The EFFICIENCY of FASCIAL PLANE BLOCKS in BARIATRIC SURGERY', 'organization': {'class': 'OTHER', 'fullName': 'V.K.V. American Hospital, Istanbul'}, 'officialTitle': 'CAN POSTOPERATIVE PAIN BE PREVENTED in BARIATRIC SURGERY? EFFICACY and USABILITY of FASCIAL PLANE BLOCKS: a RETROSPECTIVE CLINICAL STUDY', 'orgStudyIdInfo': {'id': 'Cosarcan4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAP + RB', 'description': 'transversus abdominis plane block and rectus sheath block', 'interventionNames': ['Procedure: Bariatric surgery']}, {'label': 'ESPB', 'description': 'Erector spinae plane block', 'interventionNames': ['Procedure: Bariatric surgery']}, {'label': 'EOI', 'description': 'External oblique intercostal block', 'interventionNames': ['Procedure: Bariatric surgery']}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'Patients undergoing elective bariatric surgery', 'armGroupLabels': ['EOI', 'ESPB', 'TAP + RB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34365', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'American Hsopital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'sami kaan coşarcan', 'role': 'STUDY_CHAIR', 'affiliation': 'American hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'V.K.V. American Hospital, Istanbul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sami Kaan Coşarcan', 'investigatorAffiliation': 'V.K.V. American Hospital, Istanbul'}}}}