Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-17 @ 1:26 AM
Study NCT ID:
NCT04480320
Status:
UNKNOWN
Last Update Posted:
2020-09-14
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonography-guided Pericapsular Never Group Block for Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 71}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Highest VAS score in recovery room', 'timeFrame': 'before recovery room discharge(up to 2 hours after surgery end)', 'description': 'Highest VAS score reported in recovery room,patient will be asked questions to measure the highest VAS score experienced in the recovery room before discharge. If the patient had a unexpected long stay at recovery room, the question will be asked at the time point "2 hours after surgery end"'}], 'secondaryOutcomes': [{'measure': 'VAS at rest', 'timeFrame': 'day0 ,day1 ,day2', 'description': 'VAS pain score while patient at rest'}, {'measure': 'highest VAS at period', 'timeFrame': 'day0 ,day1 ,day2', 'description': 'highest VAS reported at follow up period'}, {'measure': 'quadriceps strength', 'timeFrame': 'day0 , day1 ,day2', 'description': 'Measure quadriceps strength peak value at different time point'}, {'measure': 'total opioid consumption', 'timeFrame': 'up to 2 days after surgery'}, {'measure': 'PONV rate', 'timeFrame': 'day0 ,day1 ,day2', 'description': 'postoperative nausea and vomit'}, {'measure': 'Fall incident happened', 'timeFrame': 'up to 2 days after surgery', 'description': 'Record the fall incident happened,fall is defined as patinent accidently fall to the ground.'}, {'measure': 'Nerve block range', 'timeFrame': 'day0 , before discharge from PACU(up to 2 hours after surgery end)', 'description': 'A cotton yarn with ethanol will be put on both the surgical and nonsurgical leg to evaluate the cold sensation lost after nerve block.Skin sensation lost will be tested at lateral thigh,medial thigh,front thigh and lateral claf'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pericapsular Nerve Group', 'PENG', 'hip arthroplasty', 'Postoperative analgesia', 'quadriceps strength'], 'conditions': ['Arthroplasty', 'Nerve Block', 'Analgesia']}, 'referencesModule': {'references': [{'pmid': '34873023', 'type': 'DERIVED', 'citation': 'Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip arthroplasty as a post-operative pain management technique, study the analgesia, opioid-sparing effects and motor-blocking effects of the PENG block', 'detailedDescription': 'PENG Block group (PG) will receive 0.5%Ropivacaine in 20 ml of saline. Sham Block group (SG) will receive 20 ml of saline Patient will be sedated with IV midazolam before nerve block. After peripheral nerve block ,general anesthesia will be conducted using sufentanyl, propofol and rocuronium for induction and propofol and sevoflurane for maintenance. Tests will be operated after procedureļ¼and recorded up to 48 hours after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for hip arthroplasty\n\nExclusion Criteria:\n\n* allergy to local anesthetics\n* infection at the injection site\n* patients receiving opioids for chronic analgesic therapy\n* other lower limb neuropathies\n* inability to comprehend visual analog scale (VAS)\n* preexist cognitive dysfunction'}, 'identificationModule': {'nctId': 'NCT04480320', 'acronym': 'QUASH', 'briefTitle': 'Sonography-guided Pericapsular Never Group Block for Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou First People's Hospital"}, 'officialTitle': 'Sonography-guided Pericapsular Nerve Group Block for Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'K-2020-085-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pericapsular nerve group block', 'interventionNames': ['Procedure: pericapsular nerve group block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline placebo group', 'interventionNames': ['Procedure: pericapsular nerve group block']}], 'interventions': [{'name': 'pericapsular nerve group block', 'type': 'PROCEDURE', 'description': 'Branches of both the FN and ON provide innervation to the anterior hip capsule. High and low branches of FN provided the majority of innervation to the lateral and superomedial hip capsule. The AON innervates the medial capsule.Both of the nerve close to the periosteum between the iliopubic eminence and AIIS ,by using ultrasound guided technique,these sites can be potential bony landmarks provid approch to the nerve group.', 'armGroupLabels': ['Pericapsular nerve group block', 'Saline placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510180', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangcai Ruan, MD, PHD', 'role': 'CONTACT', 'email': 'xc_ruan@hotmail.com', 'phone': '8620-81048306'}, {'name': 'Jun Zheng, MD, Msc', 'role': 'CONTACT', 'email': 'zhengjun19861029@126.com'}, {'name': 'Xiangcai Ruan, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jun Zheng, MD, Msc', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Guangzhou First Municipal People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain', 'investigatorAffiliation': "Guangzhou First People's Hospital"}}}}