Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-08 @ 2:40 PM
Study NCT ID:
NCT07003633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Analgesia: The Effectiveness of the PENG Block in Patients With Hip Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patients will be randomized to their rescpective groups with closed envelope method.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative Pain Scores and Opioid Consumption', 'timeFrame': '24 hours preoperatively', 'description': 'Preoperative pain of patients will be assessed with NRS (Numeric Raitng Scale) which ranges from 0 (no pain) to 10 (the most severe pain imaginable).'}], 'secondaryOutcomes': [{'measure': 'Discharge Time', 'timeFrame': 'From surgery to discharge up to 30 days'}, {'measure': 'Postoperative Mortality and Morbidity', 'timeFrame': '30 days after surgery', 'description': 'Postoperative complications such as infections, embolism, chronic pain and survival status'}, {'measure': 'Opioid Consumption', 'timeFrame': '24 hours preoperatively', 'description': 'Opioid consumption will be assessed with patient controlled analgesia (PCA) device which measures analgesic drug consumption. Fentanyl consumption unit will be micrograms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analgesia', 'PENG block', 'Hip Fracture'], 'conditions': ['Hip Fracture Surgeries']}, 'descriptionModule': {'briefSummary': 'The aim is to provide effective preoperative analgesia in patients undergoing surgical procedures due to hip fractures by administering a pericapsular nerve group (PENG) block under ultrasound guidance. This approach seeks to increase patient satisfaction, reduce analgesic requirements, enable earlier discharge, and decrease morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing hip farcture surgery\n\nExclusion Criteria:\n\n* Chronic analgesics consumption\n* Patients contraindicated for neuraxial anesthesia\n* Alcohol and drug addiction\n* Allergies to local anesthetics and opioids\n* Patients who refuses to participate in the study'}, 'identificationModule': {'nctId': 'NCT07003633', 'briefTitle': 'Preoperative Analgesia: The Effectiveness of the PENG Block in Patients With Hip Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'Preoperative Analgesia: The Effect of the Pericapsular Nerve Group (PENG) Block Administered Preoperatively in Patients With Hip Fractures on Preoperative Analgesic Efficacy, Early Postoperative Discharge, Mortality, and Morbidity.', 'orgStudyIdInfo': {'id': 'E-43012747-050.04-463726-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group PENG', 'description': 'Group PENG will involve the patients who will be performed PENG block 24 hours before surgery.', 'interventionNames': ['Procedure: PENG block with 0.25% bupivacaine guided by ultrasound.']}, {'type': 'NO_INTERVENTION', 'label': 'Group Control', 'description': 'Group Control will involve the patients who will not be performed PENG block preoperatively.'}], 'interventions': [{'name': 'PENG block with 0.25% bupivacaine guided by ultrasound.', 'type': 'PROCEDURE', 'description': 'PENG (Pericapsular nerve block) is a peripheral nerve block which is performed for patients with hip fractures aimed to prevent preoperative and postoperative pain. It is performed under sterile conditions under ultrasound guideance.', 'armGroupLabels': ['Group PENG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sakarya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Alim Miniksar, M.D.', 'role': 'CONTACT', 'email': 'alimminiksar@gmail.com', 'phone': '+905069499002'}], 'facility': 'Sakarya Universtiy Training and Research Hospital', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'centralContacts': [{'name': 'Alim Miniksar, M.D.', 'role': 'CONTACT', 'email': 'alimminiksar@gmail.com', 'phone': '+905069499002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology and Reanimation Resident, M.D.', 'investigatorFullName': 'Alim Miniksar, MD', 'investigatorAffiliation': 'Sakarya University'}}}}