Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 1:35 AM
Study NCT ID:
NCT06293404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To compare the efficacy of bupivacaine 7.5 mg/ml in the duration of sensory block at dermatome T10 level', 'timeFrame': 'Within 1 minutes after anesthesia', 'description': 'sensory block time'}], 'primaryOutcomes': [{'measure': 'Hemodynamic change', 'timeFrame': 'Within 3 minutes after anesthesia', 'description': 'Heart rate'}, {'measure': 'Hemodynamic change', 'timeFrame': 'Within 5 minutes after anesthesia', 'description': 'Heart rate'}, {'measure': 'Hemodynamic change', 'timeFrame': 'Within 10 minutes after anesthesia', 'description': 'Heart rate'}, {'measure': 'Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.', 'timeFrame': '15 minutes', 'description': 'Heart rate'}, {'measure': 'Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.', 'timeFrame': '20 minutes after anesthesia', 'description': 'Heart rate'}, {'measure': 'Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position.', 'timeFrame': '30 minutes after anesthesia', 'description': 'Heart rate'}], 'secondaryOutcomes': [{'measure': 'To compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of bupivacaine 7.5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower', 'timeFrame': '10 minutes after anesthesia', 'description': 'bromage score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['position effect', 'hip fracture', 'spinal anesthesia'], 'conditions': ['Hip Fractures', 'Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'The effect of two different positions on spinal anesthesia in hip fracture surgery', 'detailedDescription': "One of the more common reasons for hospitalization in affluent nations is femoral fractures. Postpartum mortality and morbidity rates for femur fractures are significant. Mortality rates range from 5% to 8% at the time of initial admission and from 14% to 36% throughout the first year. Age-related mortality rates are rising. Surgery is necessary for femur fractures, and spinal anesthesia is frequently the recommended anaesthetic approach.\n\nAfter spinal anesthesia, hypotension is frequently seen as a result of sympathetic block and a reduction in systemic vascular resistance. The frequency of hypotension rises as the level of spinal anesthetic block increases, especially in older people. It has been demonstrated that hypotension is connected with an increased mortality rate.\n\nPreoperative fluid administration to reduce hypotension loading, lateral decubitus anesthesia posture, and spinal anesthetic dose reduction techniques have all been used.\n\nThere are several methods to enhance the quality of the block in spinal anesthesia, including local changes to the anesthetic's baricity, volume, infusion rate, and lateral decubitus position. There are numerous variables, including residency time and spinal needle type. The influence of alterations in the spinal cord inside the vertebral column on body position in the literature was examined using lumbar MR imaging. Based on these research, it was intended to study the role that alterations in spinal anesthesia played in the applications of spinal anesthesia. spinal column Hemiblock is thought to result in more stable hemodynamics during anesthesia. Studies can be found. The goal of this study is to administer semispinal anesthesia while doing spinal anesthesia. To ensure that the underlying spinal cord is impacted by the local anesthetic and to monitor the impact on unilateral block development and hemodynamic parameters, the colon is flexed and squeezed to the surgery side and anterior area of the spinal cord.\n\nThe study will take unilateral femoral fracture surgery into account. Both groups will be given spinal anesthesia in the study's lateral\n\nFirst, Group F will keep the spinal cord flexed for 10 minutes while Group N will preserve the spinal cord's normal position in lateral decubitus. The quality of the ensuing block will be compared between the two groups. When spinal anesthetic is being used, patients may feel excruciating pain while in the prescribed position.\n\nTo lessen positional pain and the impact of hemodynamic deterioration brought on by pain during spinal anesthesia, pericapsular nerve group (PENG) block will be used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-2-3\n* Hip fracture\n* 18-85 Age\n* BMI: 18-40\n\nExclusion Criteria:\n\n* ASA score of 4 and above\n* Left ventricular ejection fraction below 40%\n* Severe aortic valve stenosis\n* Obesity (BMI \\>40)\n* Presence of cardiac arrhythmia\n* Having peripheral vascular disease\n* Failure of spinal block\n* Bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT06293404', 'briefTitle': 'The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'column flexion'}, 'secondaryIdInfos': [{'id': 'AnkaraCHBilkent', 'type': 'OTHER', 'domain': 'AnkaraCHBilkent'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group F', 'description': 'the lateral decubitus position, Group F will keep the spinal cord flexed for 10 minutes,', 'interventionNames': ['Drug: Bupivacain']}, {'type': 'OTHER', 'label': 'Group N', 'description': 'the lateral decubitus position, Group N will keep the natural position of the spinal cord in lateral decubitus for 10 minutes,', 'interventionNames': ['Drug: Bupivacain']}], 'interventions': [{'name': 'Bupivacain', 'type': 'DRUG', 'description': '7.5 mg Bupivacaine hydrochloride (0.5% heavy Marcaine) will be used on spinal anesthesia. (each group)', 'armGroupLabels': ['Group F', 'Group N']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aziz Aysel, MD', 'role': 'CONTACT', 'email': 'dr.azizaysel@gmail.com', 'phone': '5336826254'}, {'name': 'Mehmet Sahap, MD', 'role': 'CONTACT', 'email': 'drsahap@gmail.com'}], 'overallOfficials': [{'name': 'Mehmet Sahap', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}