Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT06178757
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2023-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAP Block vs External Oblique Plane Block for Laparoscopic Cholecystectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D041881', 'term': 'Cholecystitis, Acute'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C074442', 'term': '1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes Assessor and participant were blinded to the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic cholecystectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group TAPB = TAP group, Group EOIB = EOB group) including 30 patients each, before entering the operating room.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-20', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global recovery scoring system (patient satisfaction scale)', 'timeFrame': 'Change from baseline score at postoperative 24 hour', 'description': 'We will use the Turkish version of Quality of Recovery / QoR-15 questionairre'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")', 'timeFrame': 'Postoperative 24 hours period', 'description': 'Change from Baseline Pain Scores at Postoperative 24 hours.'}, {'measure': 'The use of rescue analgesia', 'timeFrame': 'Postoperative 24 hours period', 'description': 'Meperidine using (Number of Participants and Concentration of Meperidine)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Cholesistectomy', 'Postoperative pain management', 'External oblique intercostal block', 'Transversus abdominis plane block'], 'conditions': ['Cholecystitis', 'Cholecystitis, Acute', 'Cholecystitis, Chronic']}, 'referencesModule': {'references': [{'pmid': '34626112', 'type': 'BACKGROUND', 'citation': 'Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.'}, {'pmid': '30635518', 'type': 'BACKGROUND', 'citation': 'Hamilton DL, Manickam BP, Wilson MAJ, Abdel Meguid E. External oblique fascial plane block. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100256. doi: 10.1136/rapm-2018-100256. Online ahead of print. No abstract available.'}, {'pmid': '30933854', 'type': 'BACKGROUND', 'citation': 'Tulgar S, Ahiskalioglu A, Selvi O, Thomas DT, Ozer Z. Similarities between external oblique fascial plane block and blockage of thoracoabdominal nerves through perichondral approach (TAPA). J Clin Anesth. 2019 Nov;57:91-92. doi: 10.1016/j.jclinane.2019.03.027. Epub 2019 Mar 29. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasound (US) guidedTransversus Abdominis Plane Block (TAPB) is performed by injecting a local anesthetic into the plane between the internal oblique and transverse abdominis muscles and provides analgesia in the anterolateral walls of the abdomen after abdominal surgery. Ultrasound-guided TAPB has been commonly used for many years.\n\nUS-guided External oblique intercostal block (EOIB) is a novel block performed by injection of local anesthetic between the external and internal oblique muscles at the level of 6th-8th ribs. This block provides abdominal analgesia between T6 and T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing TAPB and EOIB yet.\n\nIn this study, we aim to compare the effectiveness of US-guided TAPB and EOIB for postoperative analgesia management after laparoscopic cholecystectomy surgery. Our primary aim is to compare patient recovery scores (QoR15 Turkish version), our secondary aim is to compare postoperative pain scores (24-hour NRS), postoperative rescue analgesic use (opioid/meperidine), and opioid-related side effects (allergic reaction, nausea, vomiting).', 'detailedDescription': "Cholecystectomy is the most common abdominal surgery performed in developed countries and is usually performed laparoscopically. The etiology of pain after laparoscopic cholecystectomy is multifactorial and is generally considered visceral pain. Diaphragmatic nerve irritation due to CO2 insufflation into the peritoneal cavity, abdominal distension, tissue damage, damage due to dissection of the gallbladder, sociocultural situation, and individual factors play a role in the occurrence of this pain..\n\nPostoperative pain is an acute pain that is accompanied by inflammation caused by surgical stress and decreases over time with tissue healing. Pain in the postoperative period in patients undergoing laparoscopic cholecystectomy surgery is a serious problem that reduces patient comfort and delays the patient's return to work after surgery (4). Successful postoperative analgesia management prevents many of the complications such as respiratory problems and delayed mobilization (5).\n\nTransverse Abdominis Plane Block (TAPB), performed under ultrasound (US) guidance, is a block that is performed by injecting a local anesthetic into the plane between the internal oblique and transverse abdominis muscles and provides analgesia in the anterolateral walls of the abdomen after surgery. Ultrasound-guided TAPB is commonly used.\n\nTAPB provides analgesia in the abdominal region in T6-L1 dermatomes. Sonoanatomy is easy to visualize on US and the spread of local anesthetic can be seen. Analgesia occurs in several dermatomes with the cephalo-caudal spread of the local anesthetic solution. Studies are proving that TAP block is effective in some abdominal surgeries such as hysterectomy, cesarean section, cholecystectomy, inguinal hernia and prostatectomy. Sensory block areas formed by TAPB are highly variable and may result in insufficient blocks.\n\nExternal oblique block (EOIB) performed under US guidance is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia covering the T6-T10 dermatomes. There are studies in the literature proving that it provides effective analgesia (12-14). However, no study comparing TAPB and EOIP has been published yet.\n\nIn this study, we aim to compare the effectiveness of US-guided TAPB and EOIB for postoperative analgesia management after laparoscopic cholecystectomy surgery. Our primary aim is to compare patient recovery scores (QoR15 Turkish version), our secondary aim is to compare postoperative pain scores (24-hour NRS), postoperative rescue analgesic use (opioid/meperidine), and opioid-related side effects (allergic reaction, nausea, vomiting)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) classification I-II\n* Scheduled for laparoscopic cholecystectomy surgery under general anesthesia\n\nExclusion Criteria:\n\n* Bleeding diathesis\n* anticoagulant treatment\n* local anesthetics and opioid allergy\n* Infection at the site of the block\n* Patients who do not accept the procedure'}, 'identificationModule': {'nctId': 'NCT06178757', 'briefTitle': 'TAP Block vs External Oblique Plane Block for Laparoscopic Cholecystectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Comparison of Ultrasound-Guided Transversus Abdominis Plane Block (TAP) and External Oblique Plan Block (EOIB) for Postoperative Recovery and Pain Scores After Laparoscopic Cholecystectomy Surgery', 'orgStudyIdInfo': {'id': 'Medipol Hospital 35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group TAPB = Transversus abdominis plane block group', 'description': 'Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 0,5 mg/kg meperidin will be performed for rescue analgesia', 'interventionNames': ['Drug: TAPB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group EOIB = External oblique intercostal plane block group', 'description': 'Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 0,5 mg/kg meperidin will be performed for rescue analgesia', 'interventionNames': ['Drug: EOIB']}], 'interventions': [{'name': 'TAPB', 'type': 'DRUG', 'description': 'As soon as the surgical procedure is completed, TAPB will be applied before extubation. After aseptic conditions are ensured, the high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed at the level of the anterior axillary line between the 12th rib and the iliac crest, and the external oblique abdominal muscle, internal oblique abdominal muscle, and transverse abdominis muscle will be visualized. Then, using the in-plane technique, the needle will be advanced with the help of ultrasound until the needle tip reaches the space between the internal oblique and transversus abdominis muscles. After negative pressure aspiration, 5ml saline will be injected and the block location will be confirmed. Once the block location is confirmed, 20ml 0.25% bupivacaine (40ml total for each side) will be injected bilaterally.', 'armGroupLabels': ['Group TAPB = Transversus abdominis plane block group']}, {'name': 'EOIB', 'type': 'DRUG', 'description': 'As soon as the surgical procedure is completed, EOIB will be applied before extubation. After aseptic conditions are ensured, the high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath in the supine position, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed on the 6th rib in the mid-axillary line, at the line between the anterior superior iliac spine and the umbilicus. Using the In-Plane technique, 5 ml of saline will be injected between, the external oblique muscle and the rib, and the block location will be confirmed. After confirming the block location, 20 ml 0.25% bupivacaine will be applied to the plane between 6.,7., and 8. ribs and the muscles. The same procedure will be applied to the other side (a total of 40 ml 0.25% bupivacaine).', 'armGroupLabels': ['Group EOIB = External oblique intercostal plane block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'state': 'Bagcilar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bahadir Ciftci', 'investigatorAffiliation': 'Medipol University'}}}}