Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT06815393
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON of the EFFECT of TWO DIFFERENT ANALGESIS TECHNIQUES in ABDOMINAL HYSTERECTOMY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperatve Opioid Consumption', 'timeFrame': 'postoperatively 24 hours', 'description': 'The primary aim of this study is to compare the analgesic efficacy of intrathecal morphine and bilateral transversalis fascia plane block in patients undergoing elective abdominal hysterectomy, in terms of morphine consumption during the first 24 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Scores at movement and rest', 'timeFrame': 'postoperatively 24 hours', 'description': 'evaluation of pain scores during movement and rest within 24 hours postoperatively using Visual Analogue Scale'}, {'measure': 'Quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire', 'timeFrame': 'postoperative 24 hour', 'description': 'Evaluation of quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire'}, {'measure': 'Advers Event', 'timeFrame': 'postoperative 24 hour', 'description': 'incidence of side effects (nause, vomiting, urinary retention) for 24 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal hysterectomy', 'intratechal morphine', 'transversalis fascia plane block'], 'conditions': ['Abdominal Hysterectomy']}, 'descriptionModule': {'briefSummary': 'Hysterectomy is one of the most commonly performed surgical procedures after cesarean section in many countries worldwide, especially among women of reproductive age. Postoperative pain is typically managed with oral and parenteral narcotics. Patient-controlled analgesia (PCA) is an effective pain management method that provides advantages such as faster pain relief, better dosage control, and elimination of the need for timer adjustments. Facilitating the recovery process and optimizing postoperative pain management are crucial components of perioperative care. To minimize systemic opioid requirements and opioid-related side effects, multimodal analgesia combining local anesthesia, peripheral, and non-opioid analgesics has become increasingly popular.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged between 18 and 65 years classified as ASA 1 and ASA 2.\n\nExclusion Criteria:\n\n* Patients with allergies to the active substance, those with severe liver or renal insufficiency, a history of long-term nonsteroidal anti-inflammatory drug (NSAID) and opioid analgesic use, a history of gastrointestinal bleeding, peptic ulcer or inflammatory bowel disease, a history of diabetes or other neuropathic conditions, preoperative atrioventricular block and bradycardia, underlying serious respiratory diseases, a history of psychiatric disorders, patients classified as ASA stage 3 or higher, patients weighing less than 40 kg, patients unable to use the patient-controlled analgesia (PCA) device, and patients who need to discontinue the study medication during surgery for any reason will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT06815393', 'briefTitle': 'COMPARISON of the EFFECT of TWO DIFFERENT ANALGESIS TECHNIQUES in ABDOMINAL HYSTERECTOMY', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'Comparison of the Analgesic Effect of Intrathecal Morphine and Bilateral Transversus Abdominis Plane Block in Patients Undergoing Elective Abdominal Hysterectomy', 'orgStudyIdInfo': {'id': '2024-04/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Intratechal Morphine', 'interventionNames': ['Other: Intratechal Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Transversalis Fascia Plane Block', 'interventionNames': ['Other: Transversalis Fascia Plane Block']}], 'interventions': [{'name': 'Intratechal Morphine', 'type': 'OTHER', 'description': 'Prior to induction, the patient will be positioned seated, and morphine will be slowly injected intrathecally at a dose of 5 μg/kg, adjusted to the L4-L5 or L3-L4 intervertebral space using a 27G pencil point spinal needle. The injection will be administered over approximately 10 seconds', 'armGroupLabels': ['Group Intratechal Morphine']}, {'name': 'Transversalis Fascia Plane Block', 'type': 'OTHER', 'description': 'Prior to induction, patients will be positioned supine, and bilateral transversus abdominis plane (TAP) block will be performed with the aid of ultrasound. As the blocking agent, 20 cc of 0.25% bupivacaine will be used bilaterally.', 'armGroupLabels': ['Group Transversalis Fascia Plane Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'state': 'Yakutiye', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'EMİRHAN AKARSU', 'role': 'CONTACT', 'email': 'emirhanakarsu@gmail.com', 'phone': '05352832897'}, {'name': 'Emirhan Akarsu', 'role': 'CONTACT'}], 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Emirhan Akarsu', 'role': 'CONTACT', 'email': 'emirhanakarsu@gmail.com', 'phone': '+90 535 283 28 97'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resaerch Resident', 'investigatorFullName': 'Emirhan Akarsu', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}