Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-28 @ 3:19 PM
Study NCT ID:
NCT05566561
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2022-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Para-sartorial Compartment Block in Knee Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two models for this study. Parasartorial compartment block (PSCB) group, and control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores (Numerical Rating Scale-NRS)', 'timeFrame': 'Changes from baseline pain scores at postoperative 8th hour', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}], 'secondaryOutcomes': [{'measure': 'Rescue analgesia (Opioid-tramadol consumption)', 'timeFrame': 'Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.', 'description': 'The tramadol consumption as rescue analgesia will be evaluated'}, {'measure': 'Adverse events will be recorded', 'timeFrame': 'Postoperative 24 hours period', 'description': 'Adverse events; nausea, vomiting, itching'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Surgery', 'Postoperative pain management', 'Postoperative Analgesia', 'Parasartorial compartment block'], 'conditions': ['Knee Osteoarthritis', 'Knee Injuries', 'Knee Disease', 'Knee Arthritis']}, 'referencesModule': {'references': [{'pmid': '35547556', 'type': 'BACKGROUND', 'citation': 'Pascarella G, Costa F, Del Buono R, Strumia A, Cataldo R, Agro F, Carassiti M. The para-sartorial compartments (PASC) block: a new approach to the femoral triangle block for complete analgesia of the anterior knee. Anaesth Rep. 2022 May 5;10(1):e12165. doi: 10.1002/anr3.12165. eCollection 2022 Jan-Jun. No abstract available.'}, {'pmid': '34039734', 'type': 'BACKGROUND', 'citation': 'Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.'}, {'pmid': '31130273', 'type': 'BACKGROUND', 'citation': 'Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Selective blockade of the saphenous nerve branches is among the regional anesthesia techniques in knee surgery. In this block, analgesia is provided without motor block and is an essential advantage in terms of early mobilization in the postoperative period. Blockage of motor branches causes a delay in mobilization and increases the risk of falling. The vastus medialis and its medical femoral cutaneous branch are rich in the femoral triangle. Effective postoperative analgesia is provided by a femoral triangle (triangle) blockade. The intermediate femoral cutaneous nerve courses over the sartorius muscle. Anatomically, the femoral triangle follows a separate path. When the femoral triangle and the blockade of the intermediate femoral cutaneous nerve are combined, it is called PSKB block. Parasartorial compartment block (PSKB); is based on the blockade of the branches of the saphenous nerve, the two largest sensory nerves from the femoral nerve to the knee, and is predicted to provide effective postoperative analgesia in knee arthroplasty.', 'detailedDescription': 'Selective blockade of the saphenous nerve branches is among the regional anesthesia techniques in knee surgery. In this block, analgesia is provided without motor block and is an essential advantage in terms of early mobilization in the postoperative period. Blockage of motor branches causes a delay in mobilization and increases the risk of falling. The vastus medialis and its medical femoral cutaneous branch are rich in the femoral triangle. Effective postoperative analgesia is provided by a femoral triangle (triangle) blockade. The intermediate femoral cutaneous nerve courses over the sartorius muscle. Anatomically, the femoral triangle follows a separate path. When the femoral triangle and the blockade of the intermediate femoral cutaneous nerve are combined, it is called PSKB block. Parasartorial compartment block (PSKB); is based on the blockade of the branches of the saphenous nerve, the two largest sensory nerves from the femoral nerve to the knee, and is predicted to provide adequate postoperative analgesia in knee arthroplasty.\n\nPascarella et al. applied PSKB to a 58-year-old patient who underwent knee surgery under spinal anesthesia and had pain in the postoperative period and reported that the patient with a visual pain score of 9 decreased to 2 after the block.\n\nThis study, it is aimed to evaluate the effectiveness of para-sartorial canal block for postoperative analgesia management in patients undergoing knee surgery. Our primary aim is to compare postoperative opioid consumption, and our secondary aim is to evaluate postoperative pain scores (Numerical rating scale-NRS), the presence of motor blockade, first postoperative mobilization time, and side effects (allergic reaction, nausea, vomiting, etc.) associated with opioid use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ASA classification I-III,\n* Aged 18-75 years\n* Who will be scheduled for knee surgery under spinal anesthesia.\n\nExclusion Criteria:\n\n* Patients who have a history of bleeding diathesis,\n* Take anticoagulant therapy,\n* History of chronic pain before surgery,\n* Multiple trauma,\n* Who cannot assess their pain,\n* Who have been operated under spinal anesthesia,\n* Who have an infection in the area and do not accept the procedure'}, 'identificationModule': {'nctId': 'NCT05566561', 'briefTitle': 'Para-sartorial Compartment Block in Knee Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Postoperative Analgesic Efficacy of Ultrasound-guided Para-sartorial Compartment Block in Knee Surgery: A Randomized Study', 'orgStudyIdInfo': {'id': 'Medipol Hospital 31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group PSCB = Parasartorial compartment block group', 'description': 'After placing the linear ultrasound probe in the middle of the anterior superior line to the patella and spina drug, the probe will be advanced cephalad to visualize the intermediate femoral cutaneous nerve over the satrorious. Then the block will be applied. Three injections will be made with a single needle entry in the same imaging. The procedure will be completed by applying the first injection to the femoral triangle (10 ml of local anesthetic solution), the second injection to the subsartorial region (10 ml of local anesthetic solution) lateral to the femoral artery, and the third injection to the suprasartorial region (10 ml of local anesthetic solution) (total 30 ml of 0.25% solution). concentration bupivacaine). The block location will be confirmed by injecting 2 ml of saline in every three injections.', 'interventionNames': ['Drug: Postoperative analgesia management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C = Control group', 'description': 'Wound infiltration will be applied by the surgical team', 'interventionNames': ['Drug: Postoperative analgesia management']}], 'interventions': [{'name': 'Postoperative analgesia management', 'type': 'DRUG', 'description': 'Intravenous 0.5 mg/kg tramadol and 400 mg ibuprofen will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered ibuprofen iv 400 mg 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. Patients in all groups will be attached to IV PCA containing 10 mcg/ml fentanyl, 10 mcg bolus without infusion dose, and 10 min lock time protocol. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.', 'armGroupLabels': ['Group C = Control group', 'Group PSCB = Parasartorial compartment block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'state': 'Bagcilar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators will not share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary researcher', 'investigatorFullName': 'Bahadir Ciftci', 'investigatorAffiliation': 'Medipol University'}}}}