Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT05256056
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Volume Dependent Effect of Pericapsular Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Patients will be randomized using the closed envelope method. While the practitioner knows the interventions to be made, the data collector will collect the data without learning the patient's group."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A patients will be injected with 20 cc of 0.25% Bupivacaine, and Group B patients will be injected with 30 cc of 0.25% Bupivacaine'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analouge scale', 'timeFrame': 'up to 24 hours,', 'description': 'the VAS 0 means no pain, 10 means the worst pain possible'}, {'measure': 'pin-prick test', 'timeFrame': 'up to 20 minutes', 'description': 'the ability to determine the difference between sharp and dull.'}], 'secondaryOutcomes': [{'measure': 'cold sensation test', 'timeFrame': 'up to 20 minutes', 'description': 'feel the cold: 0, not feel : 1'}, {'measure': 'presence of quadriceps motor block', 'timeFrame': 'up to 24 hours', 'description': 'Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pericapsular nerve group block', 'femur fracture', 'postoperative analgesia'], 'conditions': ['Post Operative Pain', 'Femur Fracture']}, 'referencesModule': {'references': [{'pmid': '34196965', 'type': 'BACKGROUND', 'citation': 'Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.'}, {'pmid': '32232662', 'type': 'BACKGROUND', 'citation': 'Sandri M, Blasi A, De Blasi RA. PENG block and LIA as a possible anesthesia technique for total hip arthroplasty. J Anesth. 2020 Jun;34(3):472-475. doi: 10.1007/s00540-020-02768-w. Epub 2020 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'In PENG block technique, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves which innervates the hip capsule for providing analgesia without causing muscle weakness. Since the PENG block is a facial plane block, it causes a volume dependent distribution. There are a few case reposts and cadaveric studies on volume dependent effect of analgesia and motor weakness of PENG block.\n\nIn our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.', 'detailedDescription': 'Femur fracture is the one of the most common case groups and it is seen mostly in the elderly patient population with comorbidities. For these patients, perioperative, postoperative analgesia and early mobilization are important to reduce cardiopulmonary complications and morbidity. Femoral fracture operations are mostly performed under spinal anesthesia especially under unilateral spinal anesthesia to sustain more stable hemodynamics. The lateral decubitus position, which is used for unilateral spinal anesthesia, is a painful position for these patients. Intravenous opioids are used for this procedure, however they have possible side-effects, such as sedation, inhibition of respiratory, lower blood pressure. Because of these reasons, pericapsular nerve block (PENG) has been applied recently to avoid complications. By using PENG block , positioning for spinal anesthesia is easier for patients and anesthesiologists, and postoperative analgesia can be provided.\n\nBy PENG block, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves innervating the hip capsule, thus providing analgesia in patients, but muscle weakness is not expected. Becacuse PENG block is a facial plane block, it shows a volume dependent distribution. There are a few case reposts and cadaveric studies, which are showing volume depend effect of analgesia and motor weakness of PENG block.\n\nIn our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who will undergoing hip arthroplasty surgery\n* Patients over the age of 18\n* ASA I-II-III patients\n* Patients who will be operated under spinal anesthesia\n\nExclusion Criteria:\n\n* ASA IV patients, Pregnant women\n* Patients who are not suitable for spinal anesthesia\n* Patients diagnosed with Alzheimer's and dementia who cannot cooperate\n* Patients who are not suitable for peripheral nerve block (patients with infection in the injection area, with local anesthetic allergy, with coagulopathy)\n* Patients who do not want to participate in the study\n* Patients under the age of 18\n* Patients switched to general anesthesia"}, 'identificationModule': {'nctId': 'NCT05256056', 'briefTitle': 'Volume Dependent Effect of Pericapsular Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'Comparison of the Volume Dependent Effect of Pericapsular Nerve Block in Patients Operated for Femur Fracture: A Randomized Prospective Study', 'orgStudyIdInfo': {'id': '2021/516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'patients will be injected with 20 cc of 0.25% Bupivacaine', 'interventionNames': ['Drug: Bupivacain']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'patients will be injected with 30 cc of 0.25% Bupivacaine.', 'interventionNames': ['Drug: Bupivacain']}], 'interventions': [{'name': 'Bupivacain', 'type': 'DRUG', 'description': 'efficacy of bupivacaine in different volumes', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34567', 'city': 'Seyrantepe', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sisli Etfal Research and Training Hospital'}], 'overallOfficials': [{'name': 'leyla kılınç', 'role': 'STUDY_CHAIR', 'affiliation': 'şişli etfal eğitim araştırma hastanesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist medical doctor', 'investigatorFullName': 'Gamze Dilara Demir', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}