Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT07021105
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-13
First Post:
2025-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COMPARISON OF PLAIN BLOCKS FOR POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Patients will be randomly assigned into four groups using a computer-generated randomization method. According to group allocation, patients will receive the following interventions before extubation under ultrasound (US) guidance except control group.\n\nGroup E (n=20): Bilateral erector spinae plane (ESP) block Group Q (n=20): Bilateral quadratus lumborum block (QLB) Group T (n=20): Bilateral transversus abdominis plane (TAP) block Group C (Control group, n=20): No block will be applied'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption in the postoperative period', 'timeFrame': 'For postoperative 24 hours', 'description': 'Thus the primary aim of this study was to assess the morphine consumption in the postoperative period'}], 'secondaryOutcomes': [{'measure': 'pain score (VAS=0-10), patient satisfaction (0-10), the need for rescue analgesia (mg) and side effects', 'timeFrame': 'For postoperative 24 hours', 'description': 'Secondary outcomes included pain score (VAS=0-10), patient satisfaction (0-10), the need for rescue analgesia (mg) and side effects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gynecologic surgery', 'Transversus abdominis plane block', 'Erector spinae plaen block', 'Quadratus lumborum block', 'morphine consumption'], 'conditions': ['Surgery With General Anesthesia', 'Gynecologic Surgical Procedures', 'Plane Block', 'Postoperative Pain Management']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study compares the effects of transversus abdominis plane (TAP) block, quadratus lumborum block (QLB), and erector spinae plane block (ESP) on postoperative morphine consumption, pain scores, patient satisfaction, and side effects in patients undergoing gynecological abdominal laparotomy surgeries.', 'detailedDescription': 'Patients will be randomly assigned into four groups using a computer-generated randomization method. According to group allocation, patients will receive the following interventions before extubation under ultrasound (US) guidance except control group:\n\nGroup E (n=20): Bilateral erector spinae plane (ESP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the T12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle.\n\nGroup Q (n=20): Bilateral quadratus lumborum block (QLB) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under US guidance, between the iliac crest and the 12th rib.\n\nGroup T (n=20): Bilateral transversus abdominis plane (TAP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles.\n\nGroup C (Control group, n=20): No block will be applied, only the standard intravenous patient-controlled analgesia (PCA) protocol will be used.\n\nThe primary aim of this study is to assess the morphine consumption in the postoperative period, while secondary aims include pain score, patient satisfaction, the need for rescue analgesia and side effects'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '80 patients aged between 18 and 69 years, with ASA 1-2 score (mild anemia, hypertension, diabetes, obesity, etc.), who were scheduled to undergo major gynecological abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\naged between 18 and 69 years, with ASA 1-2 score scheduled to undergo major gynecological abdominal surgery\n\nExclusion Criteria:\n\nASA score 3 or above, patients younger than 18 or older than 69 years, patients with bleeding disorders or using anticoagulants, patients with a body mass index over 40, patients with known allergies to any drugs used in the study, and patients who could not or did not wish to use Patient-Controlled Analgesia (PCA) device'}, 'identificationModule': {'nctId': 'NCT07021105', 'acronym': 'ESP QLB TAP', 'briefTitle': 'COMPARISON OF PLAIN BLOCKS FOR POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'COMPARISON OF ERECTOR SPINAE PLANE BLOCK, QUADRATUS LUMBORUM BLOCK, AND TRANSVERSUS ABDOMINIS PLANE BLOCK IN POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES', 'orgStudyIdInfo': {'id': 'Decision No. 145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group E', 'description': 'Group ESP \\& QLB, TAP, Control', 'interventionNames': ['Procedure: QLB plane block', 'Procedure: TAP Block', 'Other: No intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Q', 'description': 'Group QLB \\& ESP, TAP, Control', 'interventionNames': ['Procedure: ESP Plane block', 'Procedure: TAP Block', 'Other: No intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group T', 'description': 'Group T \\& ESP, QLB, Control', 'interventionNames': ['Procedure: ESP Plane block', 'Procedure: QLB plane block', 'Other: No intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': 'Group C \\& ESP, QLB, TAP'}], 'interventions': [{'name': 'ESP Plane block', 'type': 'PROCEDURE', 'description': 'Group E (n=20): Bilateral erector spinae plane (ESP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the T12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle.', 'armGroupLabels': ['Group Q', 'Group T']}, {'name': 'QLB plane block', 'type': 'PROCEDURE', 'description': 'Group Q (n=20): Bilateral quadratus lumborum block (QLB) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under US guidance, between the iliac crest and the 12th rib.', 'armGroupLabels': ['Group E', 'Group T']}, {'name': 'TAP Block', 'type': 'PROCEDURE', 'description': 'Group T (n=20): Bilateral transversus abdominis plane (TAP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles.', 'armGroupLabels': ['Group E', 'Group Q']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'Group C (Control group, n=20): No block will be applied, only the standard intravenous patient-controlled analgesia (PCA) protocol will be used.', 'armGroupLabels': ['Group E', 'Group Q', 'Group T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01330', 'city': 'Adana', 'state': 'Sarıçam', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Hakkı Ünlügenç, Professör', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cukurova University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Considering but not decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Dr', 'investigatorFullName': 'Hakki Unlugenc', 'investigatorAffiliation': 'Cukurova University'}}}}