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NCT Number: NCT07350252

Combination of Nerve Blocks and Local Infiltration Analgesia in Knee Arthroplasty

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesiology, Trelleborg Hospital

Trelleborg, Sweden

Location status: Recruiting

About this study

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

  • Does the combination of the SN block, the NVM block of and the AFCN block togheter with LIA provide better postoperative pain control compared to LIA alone?
  • Does the above combination reduce total postoperative opioid consumption? Secondary Research Questions

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  • Does the nerve block combination facilitate earlier postoperative mobilization?
  • Does it reduce the incidence of postoperative nausea and vomiting?
  • What is the incidence of neurological complications (sensory deficits and motor impairment)?
  • Does the intervention affect length of hospital stay?

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.

  • NVM block:
  • In-plane ultrasound approach using a linear high-frequency transducer
  • Needle inserted from the lateral thigh, placed between vastus medialis and sartorius, lateral to the adductor membrane
  • Injection: 5 ml ropivacaine 5% with clonidine 1.875 micrograms per ml
  • NVM is visualized and surrounded by local anesthetic
  • SN block:
  • Same needle entry point as NVM block
  • Needle retracted and advanced toward the lateral border of the femoral artery
  • Sartorius posterior fascia is perforated; needle tip placed beside the SN
  • Injection: 10 ml ropivacaine 0.5% with clonidine 1.875 micrograms per ml
  • Hydrodissection of the adductor canal is observed; SN is completely surrounded by local anesthetic
  • AFCN block:
  • AFCN divides into multiple branches at the level of the femoral triangle
  • Nerves are located superficially above the superior sartorius fascia in loose subcutaneous fascia
  • Typically, 3-4 individual nerve branches are visualized
  • Needle retracted in-plane from the adductor canal approach
  • Individual branches blocked superficially above sartorius
  • Injection: 1 ml ropivacaine 5% with clonidine 1.875 micrograms per ml per branch
  • LIA:
  • LIA is administered by the surgeon before wound closure
  • 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously

Control Arm: LIA Only

  • LIA is administered by the surgeon before wound closure
  • 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously

Enrollment Planned Total Enrollment: 200 patients

Principal Investigators:

  • Fredrik Fellert, MD, DESA, EDIC, EDEC, PhD student, Senior Consultant, VO Planned Operations, Trelleborg Hospital, Lund University, Sweden
  • Andreas Ekman, MD, PhD, DEAA, Senior Consultant, VO Planned Operations, Trelleborg Hospital, Lund University, Sweden
  • Fredrik Sjövall, MD, Associate Professor, Senior Consultant, Department of Perioperative and Intensive Care, Malmö University Hospital, Lund University, Sweden
  • Gunnar Flivik, MD, Associate Professor, Senior Consultant, Department of Orthopedics, Lund university Hospital, Lund University, Sweden

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.

Who can participate

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

  • Pregnancy
  • Coagulopathy or other bleeding disorder that precludes regional anesthesia
  • Allergy to local anesthetics
  • Inability to understand spoken and written Swedish
  • Unwillingness to participate in the study

Treatment and study plan

Ropivacain 5 mg/ml + Clonidine

Drug

Drug used in the block

Primary outcomes

  1. Postoperative Pain Intensity: Measured using the NRS scale 0-10 at multiple predefined time points postoperatively (1 hour, 4 hours, 24 hours)

    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.

  2. Difference in analgesia consumption

    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).

Secondary outcomes

  1. Time to mobilization

    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)

  2. Incidence of postoperative nausea and vomiting

    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

  3. Neurological complications

    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.

  4. Length of Hospital Stay

    Time frame: 1-5 days post-surgery

    Number of postoperative days in hospital.

  5. Difference in postoperative pain depending on method of anesthesia

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Ekman, MD, PhD

CONTACT

[email protected]

+46702542552

Fredrik Fellert, MD

CONTACT

[email protected]

+46736552249

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Greta and Johan Kock Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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