Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062416) titled 'Prospective observational study of ultrasound-guided adductor canal block combined with popliteal plexus block for postoperative analgesia after tibial plateau fracture surgery' on July 31.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Iwate Prefectural Ofunato Hospital
Condition:
Condition - tibial plateau fracture
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To prospectively evaluate the proportion of patients requiring rescue analgesia (NSAID administration or initiation of intravenous patient-controlled analgesia [IVPCA]) within 24 hours after surgery, as well as perioperative outcomes, in patients undergoing tibial plateau fracture surgery who receive ultrasound-guided adductor canal block (ACB) combined with popliteal plexus block (PPB).
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - After induction of general anesthesia, ultrasound-guided adductor canal block (ACB) and popliteal plexus block (PPB) will be performed using 10 mL of 0.25% levobupivacaine for each block (total 20 mL, 50 mg) without adjuvants. Acetaminophen will be administered every 6 hours postoperatively. Rescue analgesia will consist of NSAID administration, followed by intravenous patient-controlled analgesia (IVPCA) if required.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Age 18 years or older.
2.Patients undergoing open reduction and internal fixation for tibial plateau fracture under general anesthesia at Iwate Prefectural Ofunato Hospital.
3.Able to understand the Numeric Rating Scale (NRS).
4.Written informed consent obtained from the patient.
Key exclusion criteria - 1.Refusal to participate.
2.Allergy to local anesthetics.
3.Infection at the injection site.
4.Coagulopathy or antithrombotic therapy contraindicating peripheral nerve block.
5.Severe pre-existing neurological deficits.
6.Suspected or confirmed acute compartment syndrome or planned fasciotomy.
7.Inability to provide written informed consent.
8.Pregnancy.
9.Patients considered unsuitable by the attending physician.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 15 Day
Date of IRB - 2026 Year 07 Month 21 Day
Anticipated trial start date - 2026 Year 07 Month 31 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071428
Disclaimer: Curated by HT Syndication.