Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06976320
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Rectus Sheath Block for Laparoscopic Cholecystectomy
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'Postoperative 24 hours', 'description': 'The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Postoperative numerical rating scale scores', 'timeFrame': 'Postoperative 24 hours', 'description': 'Postoperative pain will be assessed using a numerical rating scale (NRS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.'}, {'measure': 'Rescue analgesic drug requirement', 'timeFrame': 'Postoperative 24 hours', 'description': 'The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.'}, {'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': 'Postoperative 24 hours', 'description': 'Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholecystectomy, Laparoscopic', 'Anesthesia', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Postoperative pain after laparoscopic cholecystectomy can be considerable. Regional techniques such as erector spinae plane (ESP) block or transversus abdominis plane (TAP) block may be suitable for patients at increased risk of postoperative pain. The deep rectus sheath block is a novel block which is a modified version of the conventional rectus sheath block. It was reported in a few case reports that, it may be used for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. The aim of this study is to investigate the postoperative analgesic efficacy of deep rectus sheath block in patients undergoing laparoscopic cholecystectomy.', 'detailedDescription': 'Patients scheduled for elective laparoscopic gastrectomy will be separated into 2 groups: Control Group and Deep Rectus Sheath Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in Deep Rectus Sheath Block Group will be performed Deep Rectus Sheath Block at the end of the surgery, along with patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, numerical rating scale scores, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80 years\n* Patients with American Society of Anesthesiology (ASA) physical status I-II\n* Patients scheduled for a laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Coagulopathy\n* Skin infection at the deep rectus sheath block area\n* Advanced hepatic or renal failure\n* Chronic pain syndromes\n* Alcohol or drug abuse\n* Severe pulmonary and/or cardiovascular disease\n* Psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT06976320', 'briefTitle': 'Deep Rectus Sheath Block for Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'Deep Rectus Sheath Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'Anestezi4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia', 'interventionNames': ['Other: Intravenous morphine patient control analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deep rectus sheath block group', 'description': 'The patients in deep rectus sheath block group will be received deep rectus sheath block and patient controlled analgesia with morphine for postoperative analgesia', 'interventionNames': ['Other: Intravenous patient control analgesia', 'Other: Deep rectus sheath block']}], 'interventions': [{'name': 'Intravenous morphine patient control analgesia', 'type': 'OTHER', 'description': '24-hour morphine consumption will be recorded', 'armGroupLabels': ['Control group']}, {'name': 'Intravenous patient control analgesia', 'type': 'OTHER', 'description': '24-hour morphine consumption will be recorded', 'armGroupLabels': ['Deep rectus sheath block group']}, {'name': 'Deep rectus sheath block', 'type': 'OTHER', 'description': 'Deep rectus sheath block will be administered at the end of the surgery.', 'armGroupLabels': ['Deep rectus sheath block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Taylan Sahin, M.D.', 'role': 'CONTACT', 'email': 'taylansah@hotmail.com', 'phone': '+902129794000'}, {'name': 'Taylan Sahin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ali Sait Kavakli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istinye University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Taylan Sahin, M.D.', 'role': 'CONTACT', 'email': 'taylansah@hotmail.com', 'phone': '+902129794000'}], 'overallOfficials': [{'name': 'Taylan Sahin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istinye University'}, {'name': 'Ali Sait Kavakli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istinye University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}