Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-02 @ 12:08 AM
Study NCT ID:
NCT05939635
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2023-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Sleeve Gastrectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Researchers, surgeons and nurses, and those involved in study outcome analysis will not be aware of the randomization of the group. Block quality and standardization will be performed by an anesthetist experienced in regional anesthesia for EOIB and M-TAPA block.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2023-07-01', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption in the first 24 hours after surgery', 'timeFrame': 'Postoperative day 1', 'description': 'Morphine consumption in the first 24 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is≥ 4.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain scores', 'timeFrame': 'Postoperative day 1', 'description': 'Pain status at rest and while activity will be assessed by NRS score at 0, 3, 6, 12, 18, and 24 hours after surgery. The NRS is an 11-point numeric scale that ranges from 0 to 10.'}, {'measure': "Patients' satisfaction and quality of pain management", 'timeFrame': 'Postoperative day 1', 'description': 'Patients\' pain management satisfaction and quality will be evaluated using the QoR-15 score. The QoR-15 consists of 5 test areas: pain (2 questions), physical comfort (5 questions), physical state (2 questions), psychological state (2 questions), and emotional state (4 questions). Each question is rated on a 10-point scale ranging from 0 = "never" to 10 = "always" (scoring is reversed for negative questions).\n\nQoR-15 Turkish Version will be used for assessment.'}, {'measure': 'The incidences of postoperative nausea and vomiting (PONV)', 'timeFrame': 'Postoperative day 1', 'description': 'The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.'}, {'measure': 'Time of first analgesic request', 'timeFrame': 'Postoperative day 1', 'description': 'Time at which the first analgesic is requested'}, {'measure': 'Intraoperative remifentanil consumption', 'timeFrame': 'The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.', 'description': 'The total amount of remifentanil consumed will be recorded.'}, {'measure': 'The number of patients with complications', 'timeFrame': 'Postoperative 7 days on an average', 'description': 'The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded'}, {'measure': 'The number of patients who required rescue analgesia.', 'timeFrame': 'Postoperative day 1', 'description': 'he number of patients requiring rescue analgesics will be recorded over 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Nerve block', 'Sleeve gastrectomy', 'External oblique intercostal block'], 'conditions': ['Anesthesia', 'Regional Anesthesia', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '36575362', 'type': 'BACKGROUND', 'citation': 'Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.'}, {'pmid': '35249704', 'type': 'BACKGROUND', 'citation': 'White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.'}, {'pmid': '35994942', 'type': 'BACKGROUND', 'citation': 'Erskine RN, White L. "A review of the external oblique intercostal plane block - a novel approach to analgesia for upper abdominal surgery". J Clin Anesth. 2022 Nov;82:110953. doi: 10.1016/j.jclinane.2022.110953. Epub 2022 Aug 19. No abstract available.'}, {'pmid': '35062872', 'type': 'BACKGROUND', 'citation': 'Ibrahim M, Elnabtity AM, Hegab A, Alnujaidi OA, El Sanea O. Combined opioid free and loco-regional anaesthesia enhances the quality of recovery in sleeve gastrectomy done under ERAS protocol: a randomized controlled trial. BMC Anesthesiol. 2022 Jan 21;22(1):29. doi: 10.1186/s12871-021-01561-w.'}]}, 'descriptionModule': {'briefSummary': 'In obese patients, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea, vomiting, and analgesia. This study aimed to investigate the effects of Bilateral External Oblique Intercostal Block (EOIB) and Perichondrial Modified Thoracoabdominal Nerve Block (M-TAPA) on postoperative acute pain scores (0-24 hours) and 24-hour opioid consumption in patients who underwent laparoscopic sleeve gastrectomy.', 'detailedDescription': 'Morbid obesity patients often have multisystem physiological changes and multiple comorbidities that can significantly affect perioperative pain control. These patients may have increased side effects from inadequate acute pain management and opioids should be used with caution.\n\nRegional techniques can be applied in obese patients because they provide non-opioid analgesia and have fewer perioperative respiratory side effects. Effective pain control is associated with reduced post-operative opioid administration, faster mobilization, faster recovery, and shorter hospital stay.\n\nIntraoperative nerve blocks using local anesthetics have been shown to improve postoperative pain in various abdominal surgeries, both open and laparoscopic. Recently, it has been reported that the M-TAPA block is a promising new technique that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is delivered only to the underside of the perichondral surface.\n\nTAPA/M-TAPA block has been shown to provide a potent analgesic effect in a large abdomen by numbing both the anterior and lateral cutaneous branches of the thoracoabdominal nerves. Therefore, the TAPA/M-TAPA block has been used in various abdominal surgeries. The EOI block represents an important modification of the fascial plane block techniques that can consistently cover the upper lateral abdominal wall.\n\nWhen we look at the literature, it is seen that there are not enough studies on M-TAPA block and EOIB.\n\nThe aim of this study is to investigate the effects of Bilateral External Oblique Intercostal Block (EOIB) and Perichondrial Modified Thoracoabdominal Nerve Block (M-TAPA) on postoperative acute pain scores (0-24 hours) and 24-hour opioid consumption in patients who underwent laparoscopic sleeve gastrectomy. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, parallel-group study.\n\nPatients will be divided into two groups:\n\nGroup M-TAPA :\n\nA bilateral M-TAPA (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours.\n\nGroup EOIB :\n\nA bilateral EOIB (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between18-65 years\n* American Society of Anesthesiology score II-III\n* Body mass index (BMI) \\> 35 kg/m2\n* Patients who will sign the informed consent form\n\nExclusion Criteria:\n\n* History of opioid use for more than four weeks\n* Chronic pain syndromes\n* Patients with a history of local anesthetic or opioid allergy, hypersensitivity\n* Severe cardiac, hepatic, and renal disease\n* Alcohol and drug addiction\n* Conditions where regional anesthesia is contraindicated\n* Failure in the dermatomal examination performed after the block\n* Patients with a STOP-BANG score ≥5'}, 'identificationModule': {'nctId': 'NCT05939635', 'briefTitle': 'M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Sleeve Gastrectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Bilateral Ultrasound-guided M-Tapa Block vs External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MTAPAEOIBLSG2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group M-TAPA', 'description': 'A bilateral M-TAPA (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)', 'interventionNames': ['Procedure: Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block', 'Drug: IV morphine patient-controlled analgesia (PCA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group EOIB', 'description': 'A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)', 'interventionNames': ['Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB)', 'Drug: IV morphine patient-controlled analgesia (PCA)']}], 'interventions': [{'name': 'Bilateral ultrasound guided external oblique intercostal block (EOIB)', 'type': 'PROCEDURE', 'otherNames': ['External oblique intercostal block (EOIB)'], 'description': 'Bilateral ultrasound-guided EOIB (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, and iv paracetamol 1 gr and 0.05 mg/kg, ideal body weight (IBW), iv morphine will be administered. End of the surgery, hyoscine-N-butyl bromide will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5 mg/ml morphine (the bolus dose is 20 μg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). In cases where rescue analgesia is required (NRS score ≥4), 50 mg of meperidine is administered to patients.\n\nPatients are routinely administered ondansetron 8 mg IV 20 minutes before extubation for postoperative nausea and vomiting prophylaxis.', 'armGroupLabels': ['Group EOIB']}, {'name': 'Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block', 'type': 'PROCEDURE', 'otherNames': ['M-TAPA block'], 'description': 'Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, and iv paracetamol 1 gr and 0.05 mg/kg, ideal body weight (IBW), iv morphine will be administered. End of the surgery, hyoscine-N-butyl bromide will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5 mg/ml morphine (the bolus dose is 20 μg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). In cases where rescue analgesia is required (NRS score ≥4), 50 mg of meperidine is administered to patients.\n\nPatients are routinely administered ondansetron 8 mg IV 20 minutes before extubation for postoperative nausea and vomiting prophylaxis.', 'armGroupLabels': ['Group M-TAPA']}, {'name': 'IV morphine patient-controlled analgesia (PCA)', 'type': 'DRUG', 'otherNames': ['morphine PCA'], 'description': 'Morphine will be administered via PCA device for the first 24 hours after surgery', 'armGroupLabels': ['Group EOIB', 'Group M-TAPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55139', 'city': 'Samsun', 'state': 'Atakum', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Burhan DOST, Md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayıs University Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'BURHAN DOST', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}