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Study Comparing PENG Block and Lumbar Plexus Block for Pain Relief and Mobility After Hip Replacement Using Levobupivacaine and Sodium Chloride in Hip Surgery Patients

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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 patients undergoing Total Hip Arthroplasty, commonly known as hip replacement surgery. The study aims to compare two different methods of pain relief used during and after the surgery. These methods are known as the PENG block and the lumbar plexus block. Both techniques involve regional anesthesia, which means they target specific areas of the body to block pain. The main goal is to determine which method provides better pain relief and helps maintain the strength of the quadriceps, a muscle in the thigh, after surgery.

Participants in the study will receive one of the two anesthesia techniques. The medications used in these techniques include Levobupivacaine, a local anesthetic, and Sodium Chloride, which is often used as a solvent. The study will also include a placebo group to help compare the effectiveness of the treatments. The trial will monitor various outcomes, such as pain levels, muscle strength, and any side effects like nausea or sedation. Additionally, the study will track the need for extra pain relief, the use of opioids, and the length of hospital stay.

The purpose of this study is to improve postoperative care for patients undergoing hip replacement by identifying the most effective pain management technique. By comparing the PENG block and lumbar plexus block, researchers hope to enhance recovery and mobility after surgery, ultimately leading to better patient outcomes. The study is expected to run until early 2025, with recruitment starting in early 2024.

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

    Participation begins after agreeing to join the study and signing the informed consent form.

    Eligibility is confirmed for patients scheduled for primary hip replacement.

  2. Step 2

    Preparation for anesthesia

    The study compares two types of regional anesthesia techniques: the PENG block and the lumbar plexus block.

    These techniques are used to manage pain and improve muscle strength after hip replacement surgery.

  3. Step 3

    Administration of anesthesia

    Anesthesia is administered using a solution for injection containing sodium chloride and levobupivacaine.

    The solution is used for perineural injection, which means it is injected near the nerves.

  4. Step 4

    Postoperative care

    The primary focus is on assessing pain relief and the strength of the quadriceps muscle.

    Secondary observations include monitoring for adverse effects such as nausea, vomiting, sedation, and toxicity.

  5. Step 5

    Monitoring and evaluation

    The study evaluates the need for additional pain relief and the consumption of opioids.

    The length of hospital stay and overall pain experience are also recorded.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by January 2, 2025.

    The results will contribute to understanding the effectiveness of the anesthesia techniques in hip replacement surgery.

Who can join the trial?

5 criteria

  • Patients who are scheduled to have a **primary hip replacement**. This means they are having their hip joint replaced for the first time.
  • Patients who agree to participate in the study and sign the **informed consent**. This is a document that explains the study and confirms that the patient understands and agrees to take part.
  • Both **male and female** patients can participate.
  • Patients must be within the specified **age range**. This typically means adults, but the exact ages are not specified here.
  • The study does not include **vulnerable populations**. This usually refers to groups who might need special protection, like children or people with certain disabilities.

Who cannot join the trial?

10 criteria

  • Patients who have had a previous hip replacement surgery.
  • Patients with severe allergies to medications used in the study.
  • Patients with a history of bleeding disorders, which means their blood does not clot properly.
  • Patients who are currently taking blood-thinning medications, which help prevent blood clots.
  • Patients with severe heart or lung conditions that could make surgery risky.
  • Patients with infections in the hip area.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to give informed consent, meaning they cannot understand the study and agree to participate.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

  • PENG Block

    is a type of regional anesthesia used to provide pain relief after hip surgery. It involves injecting anesthetic near the hip joint to block pain signals from the area, helping to reduce discomfort and improve recovery after the operation.

  • Lumbar Plexus Block

    is another regional anesthesia technique used during hip replacement surgery. This method involves injecting anesthetic near the lumbar plexus, a network of nerves in the lower back, to numb the area and provide pain relief. This can help with pain management and allow for better mobility after surgery.

What is already known about the treatment

  • PENG Block

    This medication is administered through a regional anesthesia technique, specifically targeting the hip area. It is currently being studied in clinical trials to assess its effectiveness in providing pain relief and aiding mobilization after hip replacement surgery. The main therapeutic indication is for patients undergoing total hip arthroplasty. The mechanism of action involves blocking nerve signals in the hip region to reduce pain perception. It is classified under regional anesthetics.

  • Lumbar Plexus Block

    This medication is also administered as a regional anesthesia technique, focusing on the lumbar plexus nerves. It is being evaluated in clinical trials for its role in postoperative pain management and improving mobility following hip replacement surgery. The primary therapeutic use is for individuals undergoing total hip arthroplasty. Its mechanism of action involves inhibiting nerve transmission in the lumbar region to alleviate pain. It falls under the category of regional anesthetics.

Investigated diseases

Total Hip Arthroplasty – Total Hip Arthroplasty is a surgical procedure where a damaged hip joint is replaced with an artificial one. This condition often arises due to severe arthritis or injury, leading to pain and limited mobility. Over time, the joint's cartilage wears down, causing bones to rub together, resulting in discomfort and stiffness. The surgery aims to relieve pain and improve function by replacing the joint surfaces with metal, plastic, or ceramic components. Post-surgery, patients typically experience a significant reduction in pain and an improvement in joint function. Recovery involves physical therapy to restore strength and mobility in the hip.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507506-14-01Protocol codefastpengEstimated enrolment64 patientsSponsorHospital Del Mar

sourced from the EU Clinical Trials Register and site verification

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