Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-27 @ 8:30 AM
Study NCT ID:
NCT03954795
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2019-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in postoperative pain scores throughout time evaluated by VAS', 'timeFrame': 'Pain scores will be recorded for 24 hours postoperatively. The first measure will be taken immediately after surgery (time 0) and then at 2. 4. 6. 12. 24. hours.', 'description': 'Pain scores are going to be evaluated via VAS score. The VAS score will be scored between 0-10. 0 points is defined as no pain and 10 points is the most severe pain imaginable by the patient. A higher VAS score reflects a poor pain control.'}, {'measure': 'Change in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.', 'timeFrame': 'The amount of Morphine demanded by the patient will be recorded for 24 hours postoperatively. The first measure will be taken immediately after surgery (time 0) and then at 2. 4. 6. 12. 24. hours.', 'description': 'The amount of morphine demand of the patient measured through morphine delivery by the patient controlled analgesia device'}, {'measure': 'Amount of total intraoperative remifentanil infusion', 'timeFrame': 'At the end of surgery.', 'description': 'The total amount of infused remifentanil throughout the surgery will be recorded from the infusion device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TAP OSTAP Postoperative pain'], 'conditions': ['Pain Postoperative']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effectiveness and opioid sparing effects of TAP and OSTAP in patients undergoing laparoscopic cholecystectomy.', 'detailedDescription': 'Patients undergoing laparoscopic cholecystectomy were separated into 3 groups. Group 1: Received TAP block Group 2: Received OSTAP Group 3: No Block Standard General Anesthesia was induced and maintained in all patients. At the end of the operation patient controlled analgesia with morphine was applied to all patients.\n\nPain scores were evaluated at 0,2,4,6,12,24 hours postoperatively. Total morphine consumption and pain scores were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for laparoscopic cholecystectomy\n* ASA status I-II\n\nExclusion Criteria:\n\n* Local anesthetic allergy\n* Coagulopathy\n* Infection at procedure site'}, 'identificationModule': {'nctId': 'NCT03954795', 'acronym': 'OSTAP/TAP', 'briefTitle': 'OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Balikesir University'}, 'officialTitle': 'The Comparison of Analgesic Sparing Effects of Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) and Transversus Abdominis Plane Block (TAP) in Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'BAUA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: TAP Block', 'description': 'TAP Block performed from the petit triangle ( anterior axillary line and iliac crest.)', 'interventionNames': ['Procedure: TAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: OSTAP Block', 'description': 'Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.', 'interventionNames': ['Procedure: OSTAP']}, {'type': 'NO_INTERVENTION', 'label': 'No Block', 'description': 'No interventions'}], 'interventions': [{'name': 'TAP', 'type': 'PROCEDURE', 'description': 'Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest)', 'armGroupLabels': ['Group 1: TAP Block']}, {'name': 'OSTAP', 'type': 'PROCEDURE', 'description': 'Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.', 'armGroupLabels': ['Group 2: OSTAP Block']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balikesir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associated professor', 'investigatorFullName': 'Ozlem Sagir, MD', 'investigatorAffiliation': 'Balikesir University'}}}}