Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062296) titled 'Analgesic efficacy of adding vastus intermedius and vastus lateralis nerve blocks after total knee arthroplasty: A randomized controlled trial' on July 25.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - No treatment
Primary Sponsor:
Institute - Juntendo University School of Medicine
Condition:
Condition - knee osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to test the hypothesis that adding the vastus intermedius (NVI) nerve and the vastus lateralis (NVL) nerve blocks to a femoral triangle block (FTB) combined with an IPACK block improves postoperative pain scores in patients undergoing total knee arthroplasty (TKA).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Addition of vastus intermedius and vastus lateralis nerve blocks (5 mL of 0.25% levobupivacaine each)
Interventions/Control_2 - No additional vastus intermedius and vastus lateralis nerve blocks
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Participants aged between 18 and 85 years
2. Participants were scheduled for primary unilateral TKA for osteoarthritis
3. American Society of Anaesthesiologists Physical Status Classification I-III
4. Body mass index of 18-40 kg/m2
5. Written informed consent is provided
Key exclusion criteria - 1. Allergy to any drug administered in this study
2. Pre-existing lower limb motor dysfunction
3. Severe hepatic or renal dysfunction
4. Uncontrolled asthma
5. Inability to reliably assess pain
6. Severe peripheral neuropathy
7. Anticipated technical difficulty in performing the nerve blocks
8. Inability or unwillingness to comply with the study protocol
9. Chronic opioid use
Target Size - 74
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 07 Day
Date of IRB - 2026 Year 07 Month 13 Day
Anticipated trial start date - 2026 Year 08 Month 12 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071240
Disclaimer: Curated by HT Syndication.