Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-27 @ 1:03 AM
Study NCT ID:
NCT07433803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Postoperative Analgesic Efficacy of Infiltration Between the Popliteal Artery and the Capsule of the Knee (iPACK) Block and the Biceps Femoris Short Head Plane (BiFeS) Block in Total Knee Arthroplasty
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, double-blind, non-inferiority clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS Scores', 'timeFrame': 'Postoperative 8th-hour', 'description': 'A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'VAS Scores', 'timeFrame': 'Postoperative 2,4,6,12,24th-hour rest and movement', 'description': 'A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.'}, {'measure': 'Total opioid consumption', 'timeFrame': '24 hours after surgery', 'description': 'Patients with a VAS score \\> 4 will receive 1 mg/kg intravenous tramadol.'}, {'measure': 'Time to first mobilization', 'timeFrame': '24 hours after surgery', 'description': 'The postoperative hour at which the patients are comfortably mobilized is recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BiFeS Block', 'iPACK Block', 'Postoperative pain scores', 'Time to mobilization', 'Total opioid consumption'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '40418224', 'type': 'RESULT', 'citation': 'Kilicaslan A, Tulgar S, Ahiskalioglu A, Aycan IO, Kekec AF, Arici AG, Kilic G, Sindel M. Ultrasound-guided biceps femoris short head block: a novel regional anesthesia technique for the posterolateral knee. Pain Med. 2025 Nov 1;26(11):726-732. doi: 10.1093/pm/pnaf068.'}, {'pmid': '40985541', 'type': 'RESULT', 'citation': 'Sarikaya Ozel E, Taflan MG. Ultrasound-Guided Biceps Femoris Short Head Block for Posterolateral Knee Analgesia After Total Knee Arthroplasty: A Case Report. A A Pract. 2025 Sep 23;19(9):e02060. doi: 10.1213/XAA.0000000000002060. eCollection 2025 Sep 1.'}, {'pmid': '33847575', 'type': 'RESULT', 'citation': 'Akesen S, Akesen B, Atici T, Gurbet A, Ermutlu C, Ozyalcin A. Comparison of efficacy between the genicular nerve block and the popliteal artery and the capsule of the posterior knee (IPACK) block for total knee replacement surgery: A prospective randomized controlled study. Acta Orthop Traumatol Turc. 2021 Mar;55(2):134-140. doi: 10.5152/j.aott.2021.20187.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/40418224/', 'label': 'Ultrasound-guided biceps femoris short head block: a novel regional anesthesia technique for the posterolateral knee'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/33847575/', 'label': 'Comparison of efficacy between the genicular nerve block and the popliteal artery and the capsule of the posterior knee (IPACK) block for total knee replacement surgery: A prospective randomized controlled study'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/40985541/', 'label': 'Ultrasound-Guided Biceps Femoris Short Head Block for Posterolateral Knee Analgesia After Total Knee Arthroplasty: A Case Report'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effects of two regional analgesia techniques applied in patients undergoing unilateral total knee arthroplasty-Infiltration between the Popliteal Artery and the Capsule of the Knee (iPACK) block and the Biceps Femoris Short Head Plane (BiFeS) block-on ease of application, postoperative pain scores, time to mobilization, total postoperative opioid consumption, need for first rescue analgesia, and the incidence of nausea-vomiting and pruritus.All patients will be followed postoperatively according to a standard pain management protocol, and pain assessments will be performed at predetermined time intervals using the VAS (Visual Analog Scale).', 'detailedDescription': 'Total knee arthroplasty is one of the most commonly performed orthopedic procedures. Patients experience significant pain in the postoperative period. This pain delays recovery, prolongs the time to mobilization, and increases the length of hospital stay. Currently, multimodal analgesia techniques are used for postoperative pain management. These methods include systemic opioids, epidural analgesia, lumbar plexus block, femoral block, adductor canal block, iPACK block, and the newly defined and proven effective BiFeS block.\n\nIn recent years, the adductor canal block has been frequently preferred because it is applied more distally and does not cause motor blockade. It primarily provides analgesia to the anteromedial aspect of the knee.\n\nThe iPACK block and the BiFeS block can be used as complementary techniques to the adductor canal block, as they also affect the nerves responsible for the posterolateral innervation of the knee. Since they do not produce motor blockade, they are thought to contribute to early postoperative mobilization. During the iPACK block, local anesthetic is infiltrated between the posterior capsule of the knee and the popliteal artery. It has also been shown that a superior lateral genicular nerve block should be added to this block. The BiFeS block is performed with the patient in the supine position by infiltrating local anesthetic between the short head of the biceps femoris muscle and the lateral femoral condyle at a more proximal level. Due to its distance from the surgical site, the risk of infection is lower.\n\nIn this study, the investigators aimed to compare the ease of application and the roles of these blocks-routinely performed at our center as part of multimodal analgesia-in providing effective postoperative analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for unilateral total knee arthroplasty\n* Patients aged between 18 and 75 years\n* Patients with ASA physical status I-III\n\nExclusion Criteria:\n\n* Patients with neuropsychiatric disorders\n* Patients with obesity (BMI \\> 30)\n* Presence of local infection at the site where the block will be performed\n* Patients with coagulation disorders\n* Patients with uncontrolled diabetes mellitus\n* Opioid dependence\n* History of allergy to local anesthetic agents\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT07433803', 'briefTitle': 'Comparison of the Postoperative Analgesic Efficacy of Infiltration Between the Popliteal Artery and the Capsule of the Knee (iPACK) Block and the Biceps Femoris Short Head Plane (BiFeS) Block in Total Knee Arthroplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Soma State Hospital'}, 'officialTitle': 'Comparison of the Postoperative Analgesic Efficacy of Infiltration Between the Popliteal Artery and the Capsule of the Knee (iPACK) Block and the Biceps Femoris Short Head Plane (BiFeS) Block in Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Non-Inferiority Trial', 'orgStudyIdInfo': {'id': 'BiFeS2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iPACK Block', 'description': 'At the end of surgery, all patients will receive an adductor canal block in the recovery unit under sterile conditions and ultrasound guidance using 10 mL of 0.25% bupivacaine. In addition, in the iPACK block group, the patient will be positioned in the lateral decubitus position, and under sterile conditions, a linear ultrasound probe will be used to advance a 22G, 100-mm block needle to the space between the popliteal artery and the posterior capsule of the knee. After negative aspiration, an iPACK block will be performed with 25 mL of 0.25% bupivacaine.', 'interventionNames': ['Procedure: IPACK block']}, {'type': 'OTHER', 'label': 'BiFeS Block', 'description': 'At the end of surgery, all patients will receive an adductor canal block in the recovery unit under sterile conditions and ultrasound guidance using 10 mL of 0.25% bupivacaine. In addition, in the BiFeS block group, with the patient in the supine position and under sterile conditions, a linear ultrasound probe will be used, and a 22G, 100-mm block needle will be advanced to the space between the short head of the biceps femoris muscle and the lateral epicondyle of the femur. After negative aspiration, the BiFeS block will be performed using 25 mL of 0.25% bupivacaine.', 'interventionNames': ['Procedure: BiFeS Block']}], 'interventions': [{'name': 'IPACK block', 'type': 'PROCEDURE', 'description': 'Unilateral iPACK block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)', 'armGroupLabels': ['iPACK Block']}, {'name': 'BiFeS Block', 'type': 'PROCEDURE', 'description': 'Unilateral BiFeS block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)', 'armGroupLabels': ['BiFeS Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45500', 'city': 'Manisa', 'state': 'Soma', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Meltem Savas Ozdemir, MD', 'role': 'CONTACT', 'email': 'drmeltemsavas@gmail.com', 'phone': '+905557331143'}, {'name': 'Pelin Dilsiz Eker, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Soma State Hospital', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}], 'centralContacts': [{'name': 'Meltem Savas Ozdemir, MD', 'role': 'CONTACT', 'email': 'drmeltemsavas@gmail.com', 'phone': '+905557331143'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soma State Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD., specialist', 'investigatorFullName': 'Meltem Savas Ozdemir', 'investigatorAffiliation': 'Soma State Hospital'}}}}