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Study on the Effects of Bupivacaine Hydrochloride Dosage on Pain and Opioid Use After Knee Replacement Surgery for Patients with Postoperative Pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of different amounts of a local anesthetic called Bupivacaine on pain management after knee replacement surgery, also known as Total Knee Arthroplasty. The study aims to compare the use of 10 milliliters versus 20 milliliters of Bupivacaine for a specific type of nerve block called the Popliteal Plexus Block. This nerve block is used alongside another technique called the Femoral Triangle Block to help manage pain after surgery.

The purpose of the study is to see if using 20 milliliters of Bupivacaine can reduce the need for pain medications, specifically opioids, within the first 24 hours after surgery. Participants will be randomly assigned to receive either 10 milliliters or 20 milliliters of the anesthetic. The study will monitor how much pain medication is needed, the level of pain experienced, and how well patients recover after their knee surgery.

Throughout the study, researchers will collect information on various aspects of recovery, such as pain levels at rest and during movement, the ability to walk with crutches, and overall recovery quality. The goal is to determine the most effective amount of Bupivacaine for managing pain and improving recovery after knee replacement surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age over 18 years, scheduled knee surgery, and ability to provide informed consent.

    Participants must have a physical status classified as 1, 2, or 3 by the American Society of Anesthesiologists.

  2. Step 2

    Preoperative assessment

    Before surgery, pain levels in the knee are assessed using a numerical rating scale (NRS).

    This assessment helps establish a baseline for postoperative comparisons.

  3. Step 3

    Surgery and anesthesia

    The surgery is performed under spinal anesthesia.

    A Popliteal Plexus Block (PPB) is administered using either 10 mL or 20 mL of local anesthetic called bupivacaine.

    This block is part of a multimodal pain management approach, which also includes a Femoral Triangle Block.

  4. Step 4

    Postoperative period

    After surgery, opioid consumption is monitored for 24 hours, starting from the end of surgery.

    The primary goal is to measure total opioid use, expressed in oral morphine milligram equivalents.

  5. Step 5

    Pain and mobility assessment

    Pain levels at rest and during a 10-meter walk with crutches are evaluated at 6 hours and 24 hours after surgery.

    The ability to walk and muscle strength in the ankle and knee are also assessed at 6 hours post-surgery.

  6. Step 6

    Quality of recovery evaluation

    At 24 hours post-surgery, a patient-reported outcome measure called Quality of Recovery 15 is completed.

    This evaluation provides insights into the overall recovery experience.

Who can join the trial?

4 criteria

  • Must be older than 18 years.
  • Scheduled to have a **primary total knee arthroplasty**, which is a type of knee surgery, using **spinal anesthesia**. Spinal anesthesia is a way to numb the lower part of the body during surgery.
  • Must be able to understand the study and provide written consent, meaning you agree to participate after understanding what the study involves.
  • Must have an **American Society of Anesthesiologists (ASA) physical status** of 1, 2, or 3. This is a way doctors classify your overall health before surgery, with 1 being healthy and 3 having more health issues.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing postoperative pain after a Total Knee Arthroplasty (a type of knee surgery) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the specific health conditions required for the study cannot participate.
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Investigated drugs

  • Local Anesthetic

    is used in this study to provide pain relief during and after knee surgery. It is administered as part of a Popliteal Plexus Block, which is a type of nerve block that helps to numb the area around the knee. The study is comparing the effects of using two different amounts of this anesthetic to see which is more effective in reducing the need for additional pain medication after surgery.

  • Femoral Triangle Block

    is another type of nerve block used in this study. It is part of a multimodal pain management approach, which means it is used alongside other methods to control pain. This block targets nerves in the thigh area to help reduce pain after knee surgery.

What is already known about the treatment

Local Anesthetic – This medication is administered through injection as part of a Popliteal Plexus Block, which is a type of nerve block used to manage pain. It is currently being studied in clinical trials to evaluate its effectiveness in reducing postoperative pain and opioid consumption after total knee arthroplasty. The main therapeutic indication is to provide pain relief following knee surgery. At the molecular level, local anesthetics work by blocking sodium channels in nerve cells, which prevents the transmission of pain signals. They are classified pharmacologically as local anesthetics, which are commonly used to numb specific areas of the body during and after surgical procedures.

Investigated diseases

Postoperative Pain after Total Knee Arthroplasty – This condition refers to the pain experienced by patients following a surgical procedure to replace the knee joint, known as total knee arthroplasty. The pain typically arises due to the surgical trauma and the body's inflammatory response to the procedure. It can vary in intensity and may affect the patient's ability to move the knee and perform daily activities. The pain is usually most intense immediately after surgery and tends to decrease over time as the healing process progresses. Managing this pain effectively is crucial for the patient's recovery and rehabilitation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520204-26-00Estimated enrolment120 patientsSponsorRegion Midtjylland

sourced from the EU Clinical Trials Register and site verification

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