Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 10:40 AM
Study NCT ID:
NCT06337968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-25
First Post:
2024-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPB for Arthroscopic Hip Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-03-24', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain severity at 6 hours postoperatively', 'timeFrame': '6 hours postoperatively', 'description': 'Postoperative pain assessed with NRS pain score (NRS 0: no pain 10: pain as bad as can be) at 1, 6, 12, 24 hours postoperatively. However, to be more precise in our assessment, the effectiveness of each intervention was defined as a reduction in the pain at 6 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Postoperative opioid consumption', 'timeFrame': 'up to the first 24 hours postoperatively', 'description': 'Cumulative 24-hr postoperative opioid consumption'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'up to the first 24 hours postoperatively', 'description': 'Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).'}, {'measure': 'neurologic evaluation', 'timeFrame': '1, 6, 24 hours postoperatively', 'description': 'The dermatomal coverage of sensory block was evaluated by using a cool roller at 1, 6, 24 hours post-surgery. Motor strength was assessed by the following criteria (0: none; 1: muscle flicker without movement; 2: movement, but not against gravity; 3: movement against gravity; 4: movement against some resistance; 5: normal strength).'}, {'measure': 'Patient satisfaction', 'timeFrame': 'at the end of 24 hours postoperatively', 'description': 'Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain', 'Opioid Use']}, 'referencesModule': {'references': [{'pmid': '28003068', 'type': 'BACKGROUND', 'citation': 'Garner M, Alshameeri Z, Sardesai A, Khanduja V. A Prospective Randomized Controlled Trial Comparing the Efficacy of Fascia Iliaca Compartment Block Versus Local Anesthetic Infiltration After Hip Arthroscopic Surgery. Arthroscopy. 2017 Jan;33(1):125-132. doi: 10.1016/j.arthro.2016.10.010.'}, {'pmid': '21698591', 'type': 'BACKGROUND', 'citation': 'Baker JF, McGuire CM, Byrne DP, Hunter K, Eustace N, Mulhall KJ. Analgesic control after hip arthroscopy: a randomised, double-blinded trial comparing portal with intra-articular infiltration of bupivacaine. Hip Int. 2011 May-Jun;21(3):373-7. doi: 10.5301/HIP.2011.8390. Epub 2011 Jun 7.'}, {'pmid': '38026457', 'type': 'BACKGROUND', 'citation': 'Zheng J, Mi Y, Liang J, Li H, Shao P, Wen H, Wang Y. Circum-Psoas Block versus Supra-Inguinal Fascia Iliaca Block for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: A Randomized Clinical Trial. J Pain Res. 2023 Nov 20;16:3961-3970. doi: 10.2147/JPR.S435159. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.\n\nSeveral studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary unilateral ambulatory hip arthroscopy\n* Age 18 to 70 years\n* ASA physical status I to III\n* Ability to follow the protocol.\n\nExclusion Criteria:\n\n* Age \\<18 or \\>70 years of age\n* BMI above 40\n* Contraindications to peripheral nerve blockade\n* Pregnancy\n* Chronic pain condition requiring opioid intake at home\n* Allergy to opioids or local anesthetics\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT06337968', 'briefTitle': 'CPB for Arthroscopic Hip Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Shandong University'}, 'officialTitle': 'Circum-Psoas Block for Arthroscopic Hip Surgery: a Randomized Trial', 'orgStudyIdInfo': {'id': 'Circum-Psoas Block LN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guided circum-psoas block', 'description': 'Injection of 20ml 0.2% ropivacaine around the antero-lateral margin of psoas major muscle at the level of iliac crest with an in-plane approach under ultrasound guidance. Then the transducer was placed at the level of Lumbar vertebra 5 to obtain the paramedian transverse plane of the intertransverse ligament and lumbosacral ligament. An additional 20ml 0.2% ropivacaine was injected when the needle punctured the lumbosacral ligament.', 'interventionNames': ['Procedure: Circum-psoas Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham block', 'description': 'Perform ultrasound scanning without puncture.', 'interventionNames': ['Procedure: Sham block']}], 'interventions': [{'name': 'Circum-psoas Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided circum-psoas block with 40 mL of treatment drug (Ropivacaine 0.2% \\[local anesthetic\\]) 30 minutes prior to induction of anesthesia.', 'armGroupLabels': ['Ultrasound guided circum-psoas block']}, {'name': 'Sham block', 'type': 'PROCEDURE', 'description': 'Perform ultrasound scanning without puncture.', 'armGroupLabels': ['Sham block']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ning Li, Doctor', 'role': 'CONTACT', 'email': 'lining252252@126.com', 'phone': '86+13791036442'}], 'overallOfficials': [{'name': 'Ning Li, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Second Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}