Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT06837532
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Versus Surgical Rectus Sheath Block Versus Local Anesthesia Infiltration for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2025-02-15', 'studyFirstSubmitQcDate': '2025-02-15', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)\\> 3 to be repeated after 30 min if pain persists until the VAS \\< 4.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'Till the end of surgery (Up to 4 hours)', 'description': 'Heart rate will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Till the end of surgery (Up to 4 hours)', 'description': 'Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.'}, {'measure': 'Time to the first request for the rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).'}, {'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at PACU, 2, 4, 6, 12, 18, and 24h postoperatively.'}, {'measure': 'Degree of patient satisfaction', 'timeFrame': '24 hours postoperatively', 'description': 'Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).'}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse events such as hematoma, nerve damage or neuropathy, bradycardia, hypotension, nausea, vomiting, pruritis, urinary retention, or any other complication will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound', 'Surgical', 'Rectus Sheath Block', 'Local Anesthesia Infiltration', 'Postoperative Analgesia', 'Total Abdominal Hysterectomy']}, 'descriptionModule': {'briefSummary': 'The aim of this work is to compare the efficacy and safety of the effectiveness and safety of ultrasound-guided surgical rectus sheath block and local anesthetic infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.', 'detailedDescription': 'Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort.\n\nLocal anesthetic infiltration (LAI) at the end of surgery is one of the most common technique employed in laparotomies for postoperative analgesia.\n\nRectus sheath block (RSB) has been used as a part of multimodal analgesia, especially when neuraxial techniques are unsuitable.The RSB was used to achieve peri-operative relaxation of the anterior abdominal wall.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women scheduled for elective total abdominal hysterectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 65 years old.\n* American Society of Anesthesiologists (ASA) physical status I - II.\n* Patients scheduled for elective total abdominal hysterectomy under general anesthesia.\n\nExclusion Criteria:\n\n* Hepatic, renal or cardiac disease.\n* Any known allergy to local anesthetic.\n* Physical or mental conditions which may vaguely measure postoperative pain following surgery.\n* History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.'}, 'identificationModule': {'nctId': 'NCT06837532', 'briefTitle': 'Ultrasound Guided Versus Surgical Rectus Sheath Block Versus Local Anesthesia Infiltration for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Ultrasound Guided Versus Surgical Rectus Sheath Block Versus Local Anesthesia Infiltration for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Trial', 'orgStudyIdInfo': {'id': 'FMASU R23/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound-guided rectus sheath block group', 'description': 'Patients will receive ultrasound-guided rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the end of surgery.', 'interventionNames': ['Drug: Ultrasound-guided rectus sheath block']}, {'type': 'EXPERIMENTAL', 'label': 'Surgical rectus sheath block group', 'description': 'Patients will receive a surgical rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the time of closure.', 'interventionNames': ['Drug: Surgical rectus sheath block']}, {'type': 'EXPERIMENTAL', 'label': 'Local anesthesia infiltration group', 'description': 'Patients will receive local anesthesia infiltration at the end of surgery.', 'interventionNames': ['Drug: Local anesthesia infiltration']}], 'interventions': [{'name': 'Ultrasound-guided rectus sheath block', 'type': 'DRUG', 'otherNames': ['Bupivacaine'], 'description': 'Patients will receive ultrasound-guided rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the end of surgery.', 'armGroupLabels': ['Ultrasound-guided rectus sheath block group']}, {'name': 'Surgical rectus sheath block', 'type': 'DRUG', 'otherNames': ['Bupivacaine'], 'description': 'Patients will receive a surgical rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the time of closure.', 'armGroupLabels': ['Surgical rectus sheath block group']}, {'name': 'Local anesthesia infiltration', 'type': 'DRUG', 'otherNames': ['Bupivacaine'], 'description': 'Patients will receive local anesthesia infiltration at the end of surgery.', 'armGroupLabels': ['Local anesthesia infiltration group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sarah A Afifi, MD', 'role': 'CONTACT', 'email': 'Sarah606060@gmail.com', 'phone': '0501035864'}, {'name': 'Sondos Afifi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed Eldemerdash, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sarah A Afifi, MD', 'role': 'CONTACT', 'email': 'Sarah606060@gmail.com', 'phone': '0501035864'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, Intensive care, and pain management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.', 'investigatorFullName': 'Sarah Ahmed', 'investigatorAffiliation': 'Ain Shams University'}}}}