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Study on the Effect of Levobupivacaine in Reducing Chronic Pain After Open Inguinal Hernia Repair in Patients

Registered drugNo placebo
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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 chronic postsurgical pain that can occur after undergoing an open inguinal hernia mesh repair. The treatment being investigated is a technique called the transversus abdominis plane (TAP) block, which involves using a local anesthetic named Levobupivacaine. This anesthetic is administered through a local injection to help manage pain. The purpose of the study is to compare the effects of administering the TAP block before the surgical incision (preincisional) versus after the surgical incision (postincisional) on the development of chronic pain following the surgery.

Participants in the study will undergo the open inguinal hernia mesh repair procedure, which is a common surgery to fix hernias in the groin area. The study will observe the patients for a period of three months after their surgery to assess the incidence of chronic pain. The goal is to determine if the timing of the TAP block can help prevent chronic pain and reduce the need for long-term use of pain-relief medications.

This study aims to provide valuable insights into pain management strategies for patients undergoing this type of hernia repair, potentially improving recovery experiences and outcomes. By understanding the impact of the TAP block's timing, healthcare providers can better tailor pain management approaches to enhance patient comfort and reduce the risk of chronic pain after surgery.

The research process

The trial runs in 5 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, scheduled surgery, and health status.

    Written informed consent is required to participate.

  2. Step 2

    Pre-surgery preparation

    Before the surgery, a transversus abdominis plane (TAP) block may be administered. This involves a local injection of Levobupivacaine guided by ultrasound.

    The TAP block is intended to manage pain by numbing the area around the surgical site.

  3. Step 3

    Surgery

    The surgery involves an open inguinal hernia mesh repair using the Lichtenstein technique.

    The TAP block may be administered either before or after the incision, depending on the study group assignment.

  4. Step 4

    Post-surgery care

    After surgery, pain management continues as per the study protocol.

    The effectiveness of the TAP block in reducing chronic postsurgical pain is assessed.

  5. Step 5

    Follow-up assessment

    Three months after the surgery, a questionnaire (sf-IPQ) is used to evaluate the presence of chronic postsurgical pain.

    The study aims to compare pain levels between those who received the TAP block before versus after the incision.

Who can join the trial?

5 criteria

  • Patients must be over 18 years old.
  • Patients should be scheduled to have an open inguinal hernia mesh repair. This is a type of surgery to fix a hernia in the groin area using a mesh.
  • Patients must have a symptomatic inguinal hernia, which means they have noticeable symptoms, confirmed by a doctor or through an imaging test.
  • Patients need to be able to give written informed consent, meaning they understand the study and agree to participate.
  • Patients should have a clinical consideration of ASA I, II, or III. This is a classification that describes a patient's health status, where I is a healthy patient, II is a patient with mild systemic disease, and III is a patient with severe systemic disease.

Who cannot join the trial?

4 criteria

  • Patients who have not undergone open inguinal hernia mesh repair surgery.
  • Patients who do not experience **chronic postsurgical pain**. This means pain that continues for a long time after surgery.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Ultrasound-guided Transversus Abdominis Plane (TAP) Block is a type of regional anesthesia used to numb the nerves in the abdominal wall. In this clinical trial, the TAP block is being studied to see if it is more effective in reducing chronic pain after surgery when given before or after the surgical incision for open inguinal hernia mesh repair. The goal is to determine which timing of the TAP block provides better pain relief three months after the surgery.

What is already known about the treatment

Bupivacaine – Bupivacaine is administered through an injection, typically as part of a nerve block procedure. It is currently well-established in medical practice and literature as a local anesthetic. The main therapeutic indication for bupivacaine is to provide pain relief during and after surgical procedures, such as open inguinal hernia mesh repair. At the molecular level, bupivacaine works by blocking sodium channels in nerve cells, which prevents the transmission of pain signals. It is classified pharmacologically as an amide-type local anesthetic.

Investigated diseases

Chronic Postsurgical Pain – This condition occurs when pain persists for more than three months following a surgical procedure, such as open inguinal hernia mesh repair. It is characterized by ongoing discomfort or pain in the area of the surgery, which can vary in intensity and may interfere with daily activities. The pain is not due to any other underlying condition or complication from the surgery itself. It can result from nerve damage or inflammation caused by the surgical procedure. Over time, the pain may become less intense, but in some cases, it can persist and require management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513582-39-01Estimated enrolment70 patientsSponsorHospital Central De La Defensa Gomez Ulla

sourced from the EU Clinical Trials Register and site verification

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