Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT07023094
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-06-08', 'studyFirstSubmitQcDate': '2025-06-08', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Opioid Consumption', 'timeFrame': '48 hours after surgery', 'description': 'Total opiate consumption after surgery'}], 'secondaryOutcomes': [{'measure': 'Time to first rescue opioid analgesia', 'timeFrame': '48 hours after surgery', 'description': 'Time after surgery when the patient needs opiate for the first time'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '4 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '8 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '12 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '48 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'NLR', 'timeFrame': '12 hours after surgery', 'description': 'neutrophile to lymphocyte ratio'}, {'measure': 'NLR', 'timeFrame': '24 hours after surgery', 'description': 'neutrophile to lymphocyte ratio'}, {'measure': 'NLR', 'timeFrame': '48 hours after surgery', 'description': 'neutrophile to lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '12 hours after surgery', 'description': 'platelet to lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '24 hours after surgery', 'description': 'platelet to lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '48 hours after surgery', 'description': 'platelet to lymphocyte ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Disease', 'Hip Dysplasia', 'Hip Arthropathy']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial (RCT) compares the analgesic effectiveness of two regional anesthesia techniques-Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve Block (LFCB) versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB)-in pediatric patients undergoing hip surgery.', 'detailedDescription': 'Orthopedic hip procedures in pediatric patients, including osteotomies, arthroscopic interventions, and reconstructive surgeries, often result in significant postoperative pain. Effective analgesia is critical for reducing surgical stress, accelerating rehabilitation, and minimizing opioid use and associated side effects. Regional anesthesia techniques have gained attention for their opioid-sparing effects and enhanced recovery profiles.\n\nThis randomized controlled trial aims to compare the analgesic effectiveness of two regional anesthetic approaches:\n\n\\- The pericapsular nerve group (PENG) block is combined with the lateral fetal cutaneous nerve block (LFCB), targeting hip joint innervation directly and providing comprehensive sensory coverage.\n\nLumbar and sacral erector spinae plane blocks (L-ESPB and S-ESPB) employ fascial plane techniques to deliver analgesia by diffusing local anesthetic around nerves innervating the hip region.\n\nThis trial aims to establish the optimal regional anesthesia technique and determine the clinical benefits of using dexamethasone and dexmedetomidine as adjuvants. The results will guide clinicians toward evidence-based analgesic protocols in pediatric orthopedic hip surgery, potentially reducing opioid-related complications and improving patient recovery outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pediatric patients aged between 2 and 16 years.\n* Scheduled for elective orthopedic hip surgery, including: Osteotomies and Hip reconstruction surgeries\n* ASA (American Society of Anesthesiologists) physical status classification: I-III.\n* Written informed consent obtained from the patient's legal guardian(s).\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to any of the study medications\n* Presence of infection or inflammation at the intended injection site(s) of regional anesthesia.\n* Coagulopathy or bleeding disorders (including patients on anticoagulant therapy) that contraindicate nerve blocks.\n* Neurological disorders or peripheral neuropathies that could influence sensory or motor assessment of the lower limbs.\n* Cognitive impairment or behavioral disorders significantly affecting pain assessment accuracy or cooperation.\n* History of chronic opioid use or known substance abuse.\n* Severe systemic disease or condition compromising patient safety or interfering with study protocol adherence."}, 'identificationModule': {'nctId': 'NCT07023094', 'briefTitle': 'PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Comparison of Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block With Lateral Femoral Cutaneous Nerve Block (LFCB) Versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB) in Pediatric Hip Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '6/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PENG + LFCB', 'description': 'U-S guided PENG block - 0.4ml/kg 0.2% ropivacaine\n\n\\+ U-S guided LFCB - 0.1ml/kg 0.2% ropivacaine', 'interventionNames': ['Drug: Ropivacaine 0.2% for PENG Block', 'Drug: Ropivacaine 0.2% for LFCB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-ESPB + S-ESPB', 'description': 'U-S guided L-ESPB - 0.25ml/kg 0.2% ropivacaine\n\n\\+ U-S guided S-ESPB - 0.25ml/kg 0.2% ropivacaine', 'interventionNames': ['Drug: Ropivacaine 0.2% for L-ESPB', 'Drug: Ropivacaine 0.2% for S-ESPB']}], 'interventions': [{'name': 'Ropivacaine 0.2% for PENG Block', 'type': 'DRUG', 'description': 'U-S guided PENG (0.4 mL/kg) with 0.2% ropivacaine', 'armGroupLabels': ['PENG + LFCB']}, {'name': 'Ropivacaine 0.2% for LFCB', 'type': 'DRUG', 'description': 'LFCB (0.1 mL/kg) with 0.2% ropivacaine', 'armGroupLabels': ['PENG + LFCB']}, {'name': 'Ropivacaine 0.2% for L-ESPB', 'type': 'DRUG', 'description': 'Lumbar ESPB (0.25ml/kg) with 0.2% ropivacaine', 'armGroupLabels': ['L-ESPB + S-ESPB']}, {'name': 'Ropivacaine 0.2% for S-ESPB', 'type': 'DRUG', 'description': 'Sacral ESPB (0.25ml/kg) with 0.2% ropivacaine', 'armGroupLabels': ['L-ESPB + S-ESPB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Malgorzata Reysner, MD. Ph.D.', 'role': 'CONTACT', 'email': 'mreysner@ump.edu.pl', 'phone': '+608762068'}], 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Malgorzata Reysner', 'role': 'CONTACT', 'email': 'mreysner@ump.edu.pl', 'phone': '+48 61 873 83 03'}], 'overallOfficials': [{'name': 'Malgorzata Reysner, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznan University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}