Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT07233603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S-TAP vs RSB in Midline Abdominal Incision Laparotomy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale (NRS) Scores', 'timeFrame': 'Postoperative 24 hours', 'description': 'Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.'}, {'measure': 'Total tramadol consumption', 'timeFrame': 'Postoperative 24 hours', 'description': 'Postoperative total rescue analgesic need was recorded as "milligram" in unit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'regional anesthesia', 'laparotomy', 'midline incision', 'subcostal transversus abdominis plane block', 'rectus sheath block'], 'conditions': ['Postoperative Pain', 'Laparotomy']}, 'descriptionModule': {'briefSummary': 'The aim is to compare the postoperative analgesic effects of Subcostal Transversus Abdominis Plane Block (S-TAP) versus Rectus Sheath Block (RSB) in patients undergoing laparotomy with midline abdominal incision.', 'detailedDescription': 'Patients were divided into two randomized groups: Group 1 (S-TAP group, n=30) and Group 2 (RSB group, n=30). All patients will receive the same standard general anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure. After the surgery was completed, patients in Group 1 will receive subcostal transversus abdominis plane block (S-TAP) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Patients in Group 2 will receive rectus sheath block (RSB) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Routine analgesic procedure consisting of 3x1gr Paracetamol and 2x50mg Dexketoprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or higher than 4. Total Tramadol consumption will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients older than 18 years of age who underwent laparotomy with midline incision under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.\n\nExclusion Criteria:\n\n* patients who did not give consent,\n* patients with coagulopathy,\n* patients with signs of infection at the block application site,\n* patients using anticoagulants,\n* patients with local anesthetic drug allergies,\n* patients with unstable hemodynamics,\n* patients who could not cooperate during postoperative pain assessment\n* patients who received ileostomy or colostomy'}, 'identificationModule': {'nctId': 'NCT07233603', 'briefTitle': 'S-TAP vs RSB in Midline Abdominal Incision Laparotomy', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'Comparison of the Effects of Subcostal Transversus Abdominis Plane Block Versus Rectus Sheath Block on Postoperative Pain in Midline Abdominal Incision Laparotomy', 'orgStudyIdInfo': {'id': '2023-03/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'S-TAP', 'description': 'For this group, S-TAP blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For S-TAP, a high frequency linear transducer USG is placed below the xiphoid process, on the linea alba transversely. The probe will then be moved laterally along the costal margin with a slight oblique motion to match the costal arc until the transversus abdominis muscle is visualized under the rectus abdominis muscle. The block needle will be inserted in-plane from inferolateral to superomedial direction, aiming toward the fascial plane between transversus abdominis and rectus abdominis muscles. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally.', 'interventionNames': ['Procedure: Subcostal Transversus Abdominis Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RSB', 'description': 'For this group, RS blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For RSB, a high frequency linear transducer USG is placed above the umbilicus transversely. The probe will then be moved laterally until the rectus abdominis muscle, its posterior sheath and the peritoneum can be visualized clearly. The block needle will be inserted in-plane from lateral to medial direction, aiming toward the posterior sheath of the rectus abdominis muscle. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally.', 'interventionNames': ['Procedure: Rectus Sheath Block']}], 'interventions': [{'name': 'Subcostal Transversus Abdominis Plane Block', 'type': 'PROCEDURE', 'description': '20 mL of 0.25% bupivacaine on each side', 'armGroupLabels': ['S-TAP']}, {'name': 'Rectus Sheath Block', 'type': 'PROCEDURE', 'description': '20 mL of 0.25% bupivacaine on each side', 'armGroupLabels': ['RSB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'state': 'Sivas', 'country': 'Turkey (Türkiye)', 'facility': 'Sivas Cumhuriyet University', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'overallOfficials': [{'name': 'Oğuz Gündoğdu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Oguz Gundogdu', 'investigatorAffiliation': 'Cumhuriyet University'}}}}