Department of Anaesthesiology, Trelleborg Hospital
Trelleborg, Sweden
Location status: Recruiting
NCT Number: NCT07350252
The aim of this clinical randomized trial is to compare local infiltration analgesia (LIA) alone versus the combination of LIA with saphenous nerve (SN) block, block of the nerve to vastus medialis (NVM), and anterior femoral cutaneous nerve (AFCN) block in participants undergoing total knee arthroplasty (TKA). The primary outcome is pain intensity, measured using the Numerical Rating Scale (NRS) at multiple time points after surgery. Secondary outcomes include opioid consumption, time to mobilization, postoperative nausea and vomiting, length of hospital stay, neurological complications and differences in opioid consumption and NRS pain scores between general and spinal anesthesia.
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Request Info18 year and older
All sexes
Interventional
Phase 4
Trelleborg, Sweden
Location status: Recruiting
Scientific Rationale and Background Total Knee Arthroplasty (TKA) requires effective perioperative pain management. Traditionally, Local Infiltration Analgesia (LIA)has been the standard method, sometimes combined with femoral nerve block. However, femoral nerve block impairs quadriceps motor function, making early mobilization-critical for postoperative rehabilitation-difficult for participants.
Recent advances have introduced purely sensory nerve block techniques that preserve motor function. The knee joint innervation is complex and involves multiple neural pathways. The Saphenous Nerve (SN), Nervus Vastus Medialis (NVM), and the Anterior Femoral Cutaneous Nerve (AFCN) are all branches of the femoral nerve that provide sensory innervation to the knee without contributing to motor control of the quadriceps. The adductor canal contains the SN and NVM, which are primarily sensory nerves. The AFCN travels superficially in the femoral triangle and innervates the skin of the anterior and medial thigh.
Studies have shown that adductor canal block (targeting SN and NVM) combined with LIA provides comparable pain relief to femoral nerve block without motor impairment. Additionally, the AFCN contributes to sensory innervation of the anterolateral and anteromedial aspects of the knee joint. Our hypothesis is that combining these three sensory blocks (SN, NVM, and AFCN) with LIA may provide superior pain control and reduced opioid consumption compared to LIA alone, while preserving motor function necessary for early mobilization.
Primary Research Questions
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Randomization and Allocation Procedure Randomization is conducted the day before surgery by the responsible anesthesiologist using a computer-generated randomization sequence. The anesthesiologist draws a sealed randomization envelope containing the group allocation. The envelope accompanies the patient's medical record and case report forms (CRFs ) throughout the hospital stay and is verified in the operating room by the anesthesiologist.
Anesthesia type (general anesthesia with propofol and remifentanil using TCI (Target Controlled Infusion) with Eleveld pharmacokinetic model, or spinal anesthesia with 0.5% bupivacaine) is determined by clinical indication and is independent of randomization.
Arms and Interventions All patients receive standardized multimodal analgesia preoperatively: etoricoxib, paracetamol, oxycodone, and betamethasone.
Intervention Arm: Nervus Vastus Medialis (NVM) block + Saphenous Nerve (SN) block + Anterior Femoral Cutaneous Nerve (AFCN) block + Local Infilration Analgesia (LIA) All nerve blocks are performed under ultrasound guidance with strict sterile precautions.
Control Arm: LIA Only
Enrollment Planned Total Enrollment: 200 patients
Principal Investigators:
Ethical Approval Ethics Committee: Swedish Ethical Review Authority (Etikprövningsmyndigheten) Approval Reference: 2025-06626-01 Approval Date: 2025-10-30 This study is conducted in accordance with the Declaration of Helsinki and applicable Swedish regulations for clinical research, including the Act on Ethical Review of Research Involving Humans (2003:460).
Statistical Considerations:
A priori sample size calculation was performed using a two-sample t test with a significance level (alpha) of 0.05 and statistical power of 0.80, assuming a between-group difference of 2 points on the NRS pain scale. This yielded an estimated requirement of 90 participants per group to achieve adequate power. Data will be analyzed using SPSS. Descriptive statistics will be presented as appropriate for the distribution of each variable. Group comparisons will be performed using chi-square test or Fisher's exact test for categorical variables, and independent-samples t test or Mann-Whitney U test for continuous variables, depending on assessment of normality.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Undergoing primary unilateral total knee arthroplasty
Exclusion criteria
Drug used in the block
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Pain intensity was assessed using the Numeric Rating Scale (NRS) upon arrival at the post anesthesia care unit (PACU) and at 1, 2, 3 and 4 hours post-PACU admission, as well as at ward admission, on the evening of the surgery day, the morning of Postoperative Day 1 (POD1), and at discharge. At the post-surgery visit at 14 days NRS was also assessed.
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Total Postoperative Opioid Consumption: Cumulative morphine equivalents (mg) recorded during hospitalization (intraoperative and postoperative period).
Time frame: The day of surgery, postop day 1
Time to First Mobilization: Time (hours) from arrival to the PACU to first mobilization (sitting, standing, or walking as tolerated)
Time frame: The day of surgery, postop day 1
Postoperative Nausea and vomiting: Incidence and severity recorded via patient report and use of antiemetic medication
Time frame: The day of surgery, postop day 1 and at day 14 post-surgery. Patients that report or shows neurological complications at the post surgery visit day 14 will be followed up once more, 6 month after surgery.
Difference in frequency of neurological complications between groups: sensory deficits (paresthesia, numbness, hypoesthesia) and motor impairment (weakness, difficulty in muscular contraction) reported to and assessed by physiotherapist.
Time frame: 1-5 days post-surgery
Number of postoperative days in hospital.
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Exploratory analysis by anesthesia type: Comparison of pain scores (assessed by NRS (0-10)) and opioid consumption (equivalents in mg) between patients receiving general anesthesia versus spinal anesthesia
Contact information is provided by the study sponsor or research team.
Andreas Ekman, MD, PhD
CONTACT
Fredrik Fellert, MD
CONTACT
Region Skane
Other
Postoperative Analgesia in Patients Undergoing Knee Replacement Surgery - a Study Comparing Intraoperative Local Infiltration Analgesia Only With Ultrasound-guided Nerve Blocks Added to Intraoperative Local Infiltration Analgesia, a Randomized Clinical Trial
Acronym: BALIA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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