Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 5:50 PM
Study NCT ID:
NCT07467356
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the ease of spinal positioning', 'timeFrame': '30 minutes after block', 'description': 'EOSP will be assessed on the scale of 0-3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself without pain)'}], 'secondaryOutcomes': [{'measure': 'VAS at rest and on passive 15° limb lifting', 'timeFrame': '30 minutes after block 2 hours postoperatively 6 hours postoperatively 12 hours postoperatively 24 hours postoperatively', 'description': '0 no pain and 10 the strongest pain imaginable'}, {'measure': 'amount of pethidine intake', 'timeFrame': '24 hours postoperatively', 'description': 'amount of pethidine taken by the patient after surgery to relieve pain'}, {'measure': 'quality of recovery score', 'timeFrame': '24 hours after surgery', 'description': 'This questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (two-item). a numerical rating scale of 11 point for each question leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PENG block', 'anterior iliopsoas space block', 'ease of positioning', 'hip surgeries'], 'conditions': ['Pain Management']}, 'descriptionModule': {'briefSummary': 'Total hip arthroplasty (THA) has been one of the most significant advancements in orthopedic surgery over the past century. hip fractures are typically associated with severe pain, effective analgesia is crucial both before and after surgery.Spinal anesthesia (SA) is the most commonly employed method of anesthesia for repairing these fractures.The anterior iliopsoas space block is a considered as a novel technique that targets the lumbosacral trunk as it passes beneath the psoas major muscle, offering potential advantages over the traditional sacral plexus block, which is performed in the supine position.', 'detailedDescription': 'Total hip arthroplasty (THA) has been one of the most significant advancements in orthopedic surgery over the past century. hip fractures are typically associated with severe pain, effective analgesia is crucial both before and after surgery.\n\nConsequently, efforts are made to facilitate enhanced recovery profiles to reduce postoperative pain in THA patients. At present, multimodal analgesia approaches have been used for pain management after THA, including oral analgesia, epidural analgesia, and peripheral nerve block.\n\nSpinal anesthesia (SA) is the most commonly employed method of anesthesia for repairing these fractures. The intense pain resulting from the fracture can impede the optimal positioning required for these procedures , rendering access to the subarachnoid space challenging. Suboptimal postoperative analgesia may restrict limb mobility, consequently delaying recovery and increasing opioid consumption. Therefore, it is imperative to establish effective perioperative analgesia strategies that not only reduce the reliance on opioids but also mitigate their adverse effects, particularly in this patient population .\n\nBased on previous anatomical studies, it has been established that the articular branches of the femoral nerve, the obturator nerve, and the accessory obturator nerve (AON) play a crucial role in innervating the anterior hip capsule. Consequently, these nerves are identified as the primary targets for hip analgesia, and their effective blockade can be achieved through the peri-capsular nerve group (PENG) technique .\n\nRecently, The anterior iliopsoas space block is a considered as a novel technique that targets the lumbosacral trunk as it passes beneath the psoas major muscle, offering potential advantages over the traditional sacral plexus block, which is performed in the supine position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* (ASA )classes I and II\n* patients of either sex, above the age of 18 who will undergo hip surgeries( (Dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under SA with an expected duration of 2.5 hours\n\nExclusion Criteria:\n\n* patient's refusal to participate\n* any contraindications to SA or peripheral nerve blocks\n* history of ischemic heart disease\n* patients on opioids for chronic pain\n* patients with significant cognitive impairment."}, 'identificationModule': {'nctId': 'NCT07467356', 'briefTitle': 'Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Impact of Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries ;Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RC 18-2-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group (P)', 'description': 'patients will receive PENG block(using bupivacaine 0.20% 25ml).', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (A)', 'description': 'patients will receive anterior ilio-psoas space block(using bupivacaine 0.20% 25ml).', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence.', 'armGroupLabels': ['Group (P)']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'placing a patient supine, identifying the anterior superior iliac spine and iliac crest, the skin of the block region will be cleaned with 5% povidone iodine followed by 70% ethyl alcohol .Both the sterile window sheets and probe will be covered with sterile drapes. A standardised amount of local anaesthetic will be administered utilising ultrasound guidance and a portable ultrasound system (General Electric; GE, "LOGIQ P5")to visualize the iliopsoas muscle in a transverse or longitudinal scan. The needle is advanced in-plane to the fascial plane between the iliopsoas muscle and the iliofemoral ligament or iliac bone, and local anesthetic is injected to spread along the iliopsoas muscle.', 'armGroupLabels': ['Group (A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Elqalyoubea', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'fatma ahmed abdelfataah, MD', 'role': 'CONTACT', 'email': 'drfatmaahmed86@gmail.com', 'phone': '00201091921540'}], 'facility': 'Banha Faculity of Medicine', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'fatma ahmed abdelfatah, MD', 'role': 'CONTACT', 'email': 'drfatmaahmed86@gmail.com', 'phone': '00201091921540'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Fatma Ahmed Abdel Fatah', 'investigatorAffiliation': 'Benha University'}}}}