Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:16 AM
Study NCT ID:
NCT07452120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DIPB vs. SIFIB for Postoperative Analgesia After Hip Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of two parallel groups to receive either Deep Iliacus Plane Block (DIPB) or Suprainguinal Fascia Iliaca Block (SIFIB). Both interventions will be performed at the end of surgery, and outcomes will be assessed concurrently over a 48-hour postoperative period to compare analgesic efficacy, opioid consumption, motor blockade, and safety profiles between groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain intensity', 'timeFrame': '2, 4, 8, 16, 24, and 48 hours postoperatively', 'description': 'Postoperative pain assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at rest and during movement following total hip arthroplasty.'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'From the end of surgery to 48 hours postoperatively', 'description': 'Total rescue opioid consumption (intravenous tramadol) administered for postoperative pain management.'}, {'measure': 'Motor block', 'timeFrame': '4, 8, 16, 24, and 48 hours postoperatively', 'description': 'Motor blockade assessed using the Modified Bromage Scale (0-3), where higher scores indicate greater motor impairment of the lower extremity following regional anesthesia.'}, {'measure': 'Pain during movement', 'timeFrame': '2, 4, 8, 16, 24, and 48 hours postoperatively', 'description': 'Pain during movement assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain), where higher scores indicate greater pain intensity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep Iliacus Plane Block', 'Suprainguinal Fascia Iliaca Block', 'Hip Arthroplasty', 'Postoperative Pain', 'Regional Anesthesia'], 'conditions': ['Hip Arthroplasty', 'Postoperative Pain', 'Regional Anesthesia', 'Acute Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '41498358', 'type': 'BACKGROUND', 'citation': 'Tulgar S, Ciftci B, Koyuncu B, Ahiskalioglu A, Alver S, Bilal B, Sakul BU, Otu E, Narayanan M, Alici HA. Ultrasound-guided Deep Iliacus Plane Block (DIPB): Cadaveric Evaluation and Pilot Retrospective Evaluation of Another Novel Fascial Plane Block for Hip Analgesia. Turk J Anaesthesiol Reanim. 2026 Feb 9;54(1):55-61. doi: 10.4274/TJAR.2025.252252. Epub 2026 Jan 7.'}, {'pmid': '37954742', 'type': 'BACKGROUND', 'citation': 'Sekhon J, Jain R, Bansal K, Luthra N, Singh MR, Kumari B. Efficacy of Different Volumes of 0.2% Ropivacaine in Suprainguinal Fascia Iliaca Compartment Block for Multimodal Analgesia in Lower Limb Surgery. Cureus. 2023 Oct 12;15(10):e46894. doi: 10.7759/cureus.46894. eCollection 2023 Oct.'}, {'pmid': '32230895', 'type': 'BACKGROUND', 'citation': 'Lee S, Hwang JM, Lee S, Eom H, Oh C, Chung W, Ko YK, Lee W, Hong B, Hwang DS. Implementation of the Obturator Nerve Block into a Supra-Inguinal Fascia Iliaca Compartment Block Based Analgesia Protocol for Hip Arthroscopy: Retrospective Pre-Post Study. Medicina (Kaunas). 2020 Mar 27;56(4):150. doi: 10.3390/medicina56040150.'}, {'pmid': '41023795', 'type': 'BACKGROUND', 'citation': 'Saeaeh L, Chalacheewa T, Lerdwimonsak C, Phurikamonarunothai S. Comparison between combined suprainguinal fascia iliaca compartment block with intra-articular bupivacaine and suprainguinal fascia iliaca compartment block in total hip arthroplasty: randomized double blinded controlled trial. BMC Anesthesiol. 2025 Sep 29;25(1):461. doi: 10.1186/s12871-025-03345-y.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind clinical trial aims to compare the effectiveness of the Deep Iliacus Plane Block (DIPB) and the Suprainguinal Fascia Iliaca Block (SIFIB) for postoperative pain control in patients undergoing primary total hip arthroplasty. Effective analgesia after hip surgery is essential for early mobilization, reduction of complications, and improved recovery outcomes.\n\nSeventy patients scheduled for elective hip arthroplasty under spinal anesthesia will be randomly assigned to receive either DIPB or SIFIB at the end of surgery. Postoperative pain scores, opioid consumption, motor block, and block-related complications will be evaluated over a 48-hour period.\n\nThe study aims to determine whether DIPB provides superior or comparable analgesia with reduced motor blockade compared to SIFIB, thereby contributing to safer and more comprehensive postoperative pain management in hip surgery patients.', 'detailedDescription': 'Hip arthroplasty is frequently associated with moderate to severe postoperative pain, which may negatively affect early mobilization, rehabilitation, and overall recovery. Adequate postoperative analgesia is therefore essential to reduce complications such as pulmonary morbidity, thromboembolism, delirium, and prolonged hospital stay.\n\nThe hip joint is innervated by both deep articular branches (femoral, obturator, and accessory obturator nerves) and superficial cutaneous branches (femoral nerve and lateral femoral cutaneous nerve). An optimal regional analgesic technique should provide effective blockade of both components. However, currently used techniques often fail to adequately block deep capsular innervation while preserving motor function.\n\nThe suprainguinal fascia iliaca block (SIFIB) is widely used in hip surgery and effectively blocks the femoral nerve and lateral femoral cutaneous nerve, providing reliable cutaneous analgesia. Nevertheless, insufficient spread to obturator and accessory obturator nerves may result in inadequate deep joint analgesia. Attempts to overcome this limitation using high-volume injections may increase the risk of quadriceps weakness and motor blockade.\n\nThe Deep Iliacus Plane Block (DIPB) is a recently described fascial plane block targeting the deep surface of the iliacus muscle at the level of the anterior inferior iliac spine. Anatomical and preliminary clinical findings suggest that DIPB allows spread of local anesthetic to femoral, lateral femoral cutaneous, and pericapsular articular branches of the hip joint, potentially providing both capsular and cutaneous analgesia with reduced motor impairment. DIPB has therefore been proposed as a hybrid technique combining advantages of existing regional blocks.\n\nThis prospective, randomized, controlled, double-blind clinical trial will be conducted at Sivas Numune Hospital. Seventy patients (ASA I-III) scheduled for elective primary total hip arthroplasty under spinal anesthesia will be enrolled and randomly assigned into two groups: the SIFIB group (n=35) and the DIPB group (n=35). Randomization will be performed using a computer-generated sequence.\n\nAll patients will receive standardized spinal anesthesia and multimodal systemic analgesia. At the end of surgery, ultrasound-guided SIFIB or DIPB will be performed by an experienced anesthesiologist using 0.25% bupivacaine (30-40 mL, weight-adjusted). Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at rest and during movement at predetermined intervals up to 48 hours. Rescue analgesia with intravenous tramadol will be administered when NRS ≥4, and total opioid consumption will be recorded. Motor blockade will be evaluated using the modified Bromage scale. Block-related complications and adverse events will also be documented.\n\nThe primary aim of the study is to compare postoperative pain scores and opioid consumption between DIPB and SIFIB. Secondary outcomes include motor blockade, block-related complications, and overall analgesic effectiveness. The findings of this study are expected to clarify whether DIPB provides superior or comparable analgesia with less motor impairment, thereby contributing to safer and more comprehensive postoperative pain management in hip arthroplasty patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥18 years\n* ASA physical status I-III\n* Scheduled for elective primary total hip arthroplasty under spinal anesthesia\n* Ability to understand the study procedures and provide informed consent\n\nExclusion Criteria:\n\n* Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia\n* Infection at the block application site\n* Hemodynamic instability\n* Known allergy to local anesthetics\n* Pre-existing significant neurological or motor deficits in the lower extremities\n* Cognitive impairment preventing pain assessment\n* Refusal to participate or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07452120', 'briefTitle': 'DIPB vs. SIFIB for Postoperative Analgesia After Hip Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sivas Numune Hospital'}, 'officialTitle': 'Comparison of the Effects of Deep Iliacus Plane Block (DIPB) and Suprainguinal Fascia Iliaca Block (SIFIB) on Postoperative Analgesia in Patients Undergoing Hip Surgery: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'DIPB vs. SIFIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suprainguinal Fascia Iliaca Block (SIFIB)', 'description': 'Participants randomized to this arm will receive an ultrasound-guided suprainguinal fascia iliaca compartment block at the end of surgery using 0.25% bupivacaine (30-40 mL, weight-adjusted) for postoperative analgesia following primary total hip arthroplasty.', 'interventionNames': ['Procedure: Suprainguinal Fascia Iliaca Block']}, {'type': 'EXPERIMENTAL', 'label': 'Deep Iliacus Plane Block (DIPB)', 'description': 'Participants randomized to this arm will receive an ultrasound-guided deep iliacus plane block at the end of surgery using 0.25% bupivacaine (30-40 mL, weight-adjusted) for postoperative analgesia following primary total hip arthroplasty.', 'interventionNames': ['Procedure: Deep Iliacus Plane Block']}], 'interventions': [{'name': 'Suprainguinal Fascia Iliaca Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided suprainguinal fascia iliaca compartment block performed at the end of surgery using 0.25% bupivacaine (30-40 mL, weight-adjusted) for postoperative analgesia following primary total hip arthroplasty.', 'armGroupLabels': ['Suprainguinal Fascia Iliaca Block (SIFIB)']}, {'name': 'Deep Iliacus Plane Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided deep iliacus plane block performed at the end of surgery using 0.25% bupivacaine (30-40 mL, weight-adjusted) for postoperative analgesia following primary total hip arthroplasty.', 'armGroupLabels': ['Deep Iliacus Plane Block (DIPB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58050', 'city': 'Sivas', 'state': 'Sivas', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatih Balcı, MD', 'role': 'CONTACT', 'email': 'fatihbalci05@gmail.com', 'phone': '+905458647657'}], 'facility': 'Sivas Numune Hospital', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'centralContacts': [{'name': 'Fatih Balcı, MD', 'role': 'CONTACT', 'email': 'fatihbalci05@gmail.com', 'phone': '+90 545 864 76 57'}], 'overallOfficials': [{'name': 'Fatih BALCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sivas Numune Hospital, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sivas Numune Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist physician', 'investigatorFullName': 'Fatih Balcı', 'investigatorAffiliation': 'Sivas Numune Hospital'}}}}