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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.06.2024

Trial locations

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.

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 ID:
2024-513582-39-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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