Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 3:38 PM
Study NCT ID:
NCT06904703
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-29', 'studyFirstSubmitDate': '2025-03-22', 'studyFirstSubmitQcDate': '2025-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean sevoflurane MAC to achieve bispectral index (BIS) values (45-55)', 'timeFrame': 'Intraoperatively', 'description': 'Sevoflurane will be adjusted to maintain a steady state with a BIS value in the range of 45-55 and will be fixed through the study period'}], 'secondaryOutcomes': [{'measure': 'Pain degree', 'timeFrame': '24 hours postoperatively', 'description': 'Each patient will be instructed about postoperative pain assessment with the Numerical Rating Scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").Pain intensity will be measured using a 10-point NRS at rest at 2, 4, 8, 12, 18, and 24 hours postoperatively.'}, {'measure': 'Fentanyl consumption.', 'timeFrame': 'Intraoperatively', 'description': 'Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).'}, {'measure': 'Arterial blood pressure', 'timeFrame': 'Till the end of surgery (up to 2 hours)', 'description': 'MAP will be recorded pre-induction of anesthesia, post-induction of anesthesia and before performing of block, and every 15 min till the end of surgery. Intraoperative arterial blood pressure will be assessed. Hypotension (decrease in basal mean arterial blood pressure by 20%) will be treated with IV fluid.'}, {'measure': 'Heart rate', 'timeFrame': 'Till the end of surgery (up to 2 hours)', 'description': 'HR will be recorded pre-induction of anesthesia, post-induction of anesthesia and before performing of block, and every 15 min till the end of surgery.'}, {'measure': 'Total postoperative morphine consumption.', 'timeFrame': 'First 24 hours after surgery', 'description': 'Total postoperative morphine consumption in the first 24h after surgery will be recorded. Rescue analgesia of morphine will be given as 0.05mg/kg bolus if the Numerical Rating Scale (NRS) \\> 3 to be repeated after 30 min if pain persists until the NRS \\< 4.'}, {'measure': 'Patient satisfaction', 'timeFrame': '24 hours after surgery', 'description': 'Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied). It will be assessed 24 hours after surgery.'}, {'measure': 'Complications', 'timeFrame': '24 hours Postoperatively', 'description': 'Complications such as bradycardia, hypotension, nausea, vomiting, pruritis, respiratory depression will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pericapsular Nerve', 'Lumbar Erector Spinae Plane Blocks', 'Geriatrics', 'Total Hip Arthroplasty', 'General Anesthesia']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the effect of pericapsular nerve group and erector spinae plane block as adjuvants to general anesthesia in geriatrics undergoing total hip arthroplasty.', 'detailedDescription': "Total hip arthroplasty is one of the most common major orthopedic procedures to improve a patient's functional status and quality of life. Total hip arthroplasty is one of the most cost-effective and consistently successful surgeries performed in orthopedics and can be associated with significant postoperative pain.\n\nGeneral anesthesia may be considered more versatile and suitable for patients with complex medical histories or those who cannot tolerate spinal anesthesia. However, older patients undergoing hip fracture surgery under general anesthesia may experience a higher risk of postoperative delirium, prolonged sedation, and respiratory complications. Moreover, delayed mobilization is possible, leading to a higher incidence of complications such as deep vein thrombosis and pressure sores.\n\nThe target nerves of the hip joint arise from the lumbar plexus (L1-L4), the lumbosacral trunk of the sacral plexus (L4-L5), and the sacral spinal nerves (S1-S4) (7). The femoral nerve, obturator nerve, and the accessory obturator nerve supply the anterior capsule of the hip; the sciatic nerve and the nerve to the quadratus femoris mostly supply the articular branches to the posterior capsule of the hip joint The erector spinae plane block is a novel inter-fascial plane block targets the dorsal and ventral rami of the spinal nerves, is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. This block can potentially provide analgesia to the posterior pelvis potentially safer alternative to epidural or paravertebral techniques, areas often involved in hip fracture pain.\n\nThe pericapsular nerve group block targets the articular branches of the femoral and obturator nerves near the hip joint capsule. By blocking these nerves, the pericapsular nerve group block effectively provides analgesia to the hip joint, particular tissues, and proximal femur."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>75 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) classification I-III.\n* Undergoing total hip arthroplasty under general anesthesia.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Body mass index (BMI) \\> 30 kg/m2.\n* Allergy to local anesthesia drugs.\n* Infection at the site of intervention.\n* Coagulopathies.\n* Preexisting advanced diseases of the kidney or liver.'}, 'identificationModule': {'nctId': 'NCT06904703', 'briefTitle': 'Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Combination of Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty Under General Anesthesia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36265MD311/11/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'General anesthesia group', 'description': 'Patients will receive general anesthesia.', 'interventionNames': ['Drug: General anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Erector spinae plane block group', 'description': 'Patients will receive general anesthesia and erector spinae plane block.', 'interventionNames': ['Drug: Bupivacaine 0.5%']}, {'type': 'EXPERIMENTAL', 'label': 'Pericapsular nerve block group', 'description': 'Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block.', 'interventionNames': ['Drug: Bupivacaine 0.5%']}], 'interventions': [{'name': 'General anesthesia', 'type': 'DRUG', 'description': 'Patients will receive general anesthesia.', 'armGroupLabels': ['General anesthesia group']}, {'name': 'Bupivacaine 0.5%', 'type': 'DRUG', 'otherNames': ['Erector spinae plane block'], 'description': 'Patients will receive general anesthesia and erector spinae plane block.', 'armGroupLabels': ['Erector spinae plane block group']}, {'name': 'Bupivacaine 0.5%', 'type': 'DRUG', 'otherNames': ['Pericapsular nerve block'], 'description': 'Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block.', 'armGroupLabels': ['Pericapsular nerve block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mai El Hamada, MSc', 'role': 'CONTACT', 'email': 'drmai7amada93@gmail.com', 'phone': '00201285851295'}, {'name': 'Lobna M Elnasr, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ayman A Youssef, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Motaz M Abosabaa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mostafa I Sharaf, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mai El Hamada, MSc', 'role': 'CONTACT', 'email': 'drmai7amada93@gmail.com', 'phone': '00201285851295'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one yea', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management Department, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mai El-saieed Abdelghaffar Hamada', 'investigatorAffiliation': 'Tanta University'}}}}