Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-02-22 @ 7:07 PM
Study NCT ID:
NCT04871061
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2021-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2021-04-25', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores on the Numeric Rating Scale (NRS)', 'timeFrame': 'Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)', 'description': 'Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").'}], 'secondaryOutcomes': [{'measure': 'Duration of spinal anesthesia performance', 'timeFrame': 'Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)', 'description': 'It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal'}, {'measure': "Quality of patient's position", 'timeFrame': 'Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)', 'description': 'The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"'}, {'measure': 'Analgesic consumption', 'timeFrame': '24 hours', 'description': 'In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip fracture, postoperative analgesia, positioning pain'], 'conditions': ['Pain, Acute']}, 'referencesModule': {'references': [{'pmid': '25068412', 'type': 'RESULT', 'citation': 'Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.'}, {'pmid': '37715173', 'type': 'DERIVED', 'citation': 'Aygun H, Tulgar S, Yigit Y, Tasdemir A, Kurt C, Genc C, Bilgin S, Senoglu N, Koksal E. Effect of ultrasound-guided pericapsular nerve group (PENG) block on pain during patient positioning for central nervous blockade in hip surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Sep 15;23(1):316. doi: 10.1186/s12871-023-02245-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hip fracture\n* aged between 35 and 90 years old\n\nExclusion Criteria:\n\n* contraindications for spinal anesthesia and PENG block\n* impaired cognition or dementia\n* multiple fractures\n* any previous analgesic administration during the last 12 hours'}, 'identificationModule': {'nctId': 'NCT04871061', 'briefTitle': 'Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cigli Regional Training Hospital'}, 'officialTitle': 'Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients', 'orgStudyIdInfo': {'id': 'PENG55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PENG Block', 'description': 'For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia.', 'interventionNames': ['Procedure: PENG Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'in this group, standardised opioid doses (drug: Fentanyl) will be used for analgesia for positioning pain', 'interventionNames': ['Drug: Conventional opioid analgesia (Fentanyl)']}], 'interventions': [{'name': 'PENG Block', 'type': 'PROCEDURE', 'description': 'Pericapsular Nerve Group Block', 'armGroupLabels': ['PENG Block']}, {'name': 'Conventional opioid analgesia (Fentanyl)', 'type': 'DRUG', 'description': 'standardised intravenous opioid', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35575', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Hakan Aygün', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Hakan Aygun, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cigli RTH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cigli Regional Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Hakan Aygün', 'investigatorAffiliation': 'Cigli Regional Training Hospital'}}}}