Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT07023120
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PENG Block Optimization: Volume and Dexamethasone Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, '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': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-01', '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': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first rescue opioid', 'timeFrame': '24 hours after surgery', 'description': 'Time after surgery when the patient needs opiate for the first time'}], 'secondaryOutcomes': [{'measure': 'Total 48h opioid consumption', 'timeFrame': '48 hours after surgery', 'description': 'Total opiate consumption after surgery'}, {'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'}, {'measure': 'Quadriceps strength', 'timeFrame': '4 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Quadriceps strength', 'timeFrame': '8 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Quadriceps strength', 'timeFrame': '12 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Quadriceps strength', 'timeFrame': '24 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Quadriceps strength', 'timeFrame': '48 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'blood glucose', 'timeFrame': '12 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'blood glucose', 'timeFrame': '24 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'blood glucose', 'timeFrame': '48 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'Nerve damage', 'timeFrame': '12 hours after surgery', 'description': 'Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)'}, {'measure': 'Nerve damage', 'timeFrame': '24 hours after surgery', 'description': 'Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)'}, {'measure': 'Nerve damage', 'timeFrame': '48 hours after surgery', 'description': 'Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Arthropathy', 'Hip Osteoarthritis', 'Hip Arthritis']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigates the impact of local anesthetic volume and perineural dexamethasone on the analgesic and anti-inflammatory effectiveness of the pericapsular nerve group (PENG) block in patients undergoing total hip arthroplasty (THA). Patients were randomized to receive one of four PENG block variants differing in ropivacaine volume (10 mL or 20 mL of 0.2%) and the addition of 4 mg of perineural dexamethasone. The study evaluates postoperative pain, opioid requirements, systemic inflammatory markers, and quadriceps motor preservation.', 'detailedDescription': 'The pericapsular nerve group (PENG) block has become a widely used motor-sparing component of multimodal analgesia for total hip arthroplasty (THA). However, its optimal formulation-particularly the volume of local anesthetic and the role of adjuvants-remains undetermined. This prospective, double-blind, randomized controlled trial evaluates the influence of ropivacaine volume (10 mL vs. 20 mL of 0.2%) and the addition of perineural dexamethasone (4 mg) on analgesic efficacy, opioid consumption, systemic inflammation, and quadriceps strength preservation.\n\nA total of 120 adult patients undergoing unilateral THA under spinal anesthesia were randomized to one of four PENG block groups:\n\nGroup 1: 20 mL of 0.2% ropivacaine (standard-volume PENG) Group 2: 20 mL of 0.2% ropivacaine + 4 mg perineural dexamethasone Group 3: 10 mL of 0.2% ropivacaine (low-volume PENG) Group 4: 10 mL of 0.2% ropivacaine + 4 mg perineural dexamethasone The primary outcome was the time to first rescue opioid analgesia. Secondary outcomes included total 48-hour opioid consumption (expressed in oral morphine equivalents), numeric rating scale (NRS) pain scores, quadriceps muscle strength, neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR) at 12, 24, and 48 hours postoperatively.\n\nResults demonstrated that the addition of dexamethasone, regardless of volume, significantly prolonged the duration of analgesia and reduced opioid consumption compared to non-adjuvanted PENG blocks. The low-volume + dexamethasone group achieved comparable analgesia to high-volume protocols with better inflammatory profiles. Quadriceps strength was preserved in all groups. These findings support the use of perineural dexamethasone as an effective enhancer of PENG block analgesia while enabling lower local anesthetic volume, potentially improving safety and recovery outcomes in THA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥18 years scheduled for primary unilateral total hip arthroplasty (THA).\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Ability to provide written informed consent.\n* Spinal anesthesia planned as the primary anesthetic technique.\n* Body mass index (BMI) between 18 and 35 kg/m².\n* Fluent in the local language and able to understand the NRS pain scoring system.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to ropivacaine, dexamethasone, or other amide local anesthetics.\n* Pre-existing neurological deficits or neuropathies affecting lower limb motor or sensory function.\n* Chronic opioid use (daily use \\>30 mg oral morphine equivalents for \\>1 month prior to surgery).\n* History of coagulopathy, current anticoagulant therapy not eligible for regional anesthesia.\n* Uncontrolled diabetes mellitus (HbA1c \\> 9%) or active systemic infection.\n* Pregnancy or breastfeeding.\n* Previous surgery or implantation on the ipsilateral hip.\n* Inability to cooperate with postoperative assessments or participate in follow-up.'}, 'identificationModule': {'nctId': 'NCT07023120', 'briefTitle': 'PENG Block Optimization: Volume and Dexamethasone Effects', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Optimizing PENG Block in Hip Arthroplasty: Influence of Ropivacaine Volume and Dexamethasone on Analgesic Efficacy', 'orgStudyIdInfo': {'id': '8/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PENG 20 mL', 'description': 'Ultrasound-guided PENG block - 20ml 0,2% ropivacaine', 'interventionNames': ['Drug: Ropivacaine 0.2% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PENG 20 mL + DEX', 'description': 'Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone', 'interventionNames': ['Drug: Ropivacaine 0.2% Injectable Solution', 'Drug: Dexamethasone 4mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PENG 10 mL', 'description': 'Ultrasound-guided PENG block - 10ml 0,2% ropivacaine', 'interventionNames': ['Drug: Ropivacaine 0.2% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PENG 10 mL + DEX', 'description': 'Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone', 'interventionNames': ['Drug: Dexamethasone 4mg', 'Drug: Ropivacaine 0.2% Injectable Solution']}], 'interventions': [{'name': 'Ropivacaine 0.2% Injectable Solution', 'type': 'DRUG', 'description': '20ml 0.2% Ropivacaine', 'armGroupLabels': ['PENG 20 mL', 'PENG 20 mL + DEX']}, {'name': 'Dexamethasone 4mg', 'type': 'DRUG', 'description': 'perineural 4mg Dexamethasone', 'armGroupLabels': ['PENG 10 mL + DEX', 'PENG 20 mL + DEX']}, {'name': 'Ropivacaine 0.2% Injectable Solution', 'type': 'DRUG', 'description': '10ml 0.2% Ropivacaine', 'armGroupLabels': ['PENG 10 mL', 'PENG 10 mL + DEX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Malgorzata Reysner, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'mreysner@ump.edu.pl'}], 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Tomasz Reysner, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'treysner@ump.edu.pl', 'phone': '+48 (61) 873-83-03'}, {'name': 'Malgorzata Reysner, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'mreysner@ump.edu.pl', 'phone': '+48 (61) 873-83-03'}], 'overallOfficials': [{'name': 'Malgorzata Reysner, M.D. Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Poznan University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}