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Study on the Effect of Ropivacaine Hydrochloride and Sodium Chloride on Recovery After Inguinal Hernia Surgery for Patients Undergoing Open Surgery

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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 improving recovery after inguinal hernia surgery, which is a common procedure to repair a bulge in the lower abdominal area. The study is investigating the effectiveness of two types of pain relief methods: the medial transversus abdominis plane (TAP) block and the rectus sheath block. These methods involve using a local anesthetic called ropivacaine hydrochloride, which is injected to numb specific areas and help manage pain after surgery. The trial aims to determine if using both the TAP block and rectus sheath block together is more beneficial than using the TAP block alone.

Participants in the study will undergo open inguinal hernia surgery and receive either the combined block treatment or a single block treatment. The study will monitor the amount of pain relief medication needed during and after surgery, as well as the level of pain experienced by participants. Other aspects being observed include any feelings of nausea after surgery, the need for additional pain relief, and any complications that may arise during or after the procedure.

The trial will also assess participants' overall satisfaction with their pain management and any feelings of anxiety or depression they may experience. The goal is to find the most effective way to manage pain and improve recovery for patients undergoing inguinal hernia 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, language proficiency, and diagnosis of an inguinal hernia scheduled for open surgery.

  2. Step 2

    Pre-surgery preparation

    Before surgery, a detailed explanation of the procedure and the study's objectives is provided. The main objective is to assess the effectiveness of two types of pain blocks during and after surgery.

  3. Step 3

    Surgery and pain management

    During surgery, a combination of medial transversus abdominis plane (TAP) block and rectus sheath block is used to manage pain. These blocks involve the injection of ropivacaine hydrochloride, a local anesthetic, to numb the surgical area.

    The effectiveness of these blocks is compared to using the TAP block alone.

  4. Step 4

    Post-surgery recovery

    After surgery, pain management continues with the use of sodium chloride solution for infusion if necessary. The primary focus is on monitoring morphine consumption and managing pain effectively.

    The recovery process includes assessing pain levels, nausea, and overall satisfaction with pain treatment.

  5. Step 5

    Follow-up and evaluation

    Follow-up evaluations occur over seven days post-surgery. These include monitoring pain levels, any nausea or vomiting, and the need for additional pain relief.

    Patient feedback on the effectiveness of the pain management is collected, along with any complications or additional hospital visits.

Who can join the trial?

5 criteria

  • Must be able to give a written informed consent, which means you understand the study and agree to participate.
  • Must be aged 18 years or older at the time of screening.
  • Must have been diagnosed with an inguinal hernia and be scheduled for open inguinal hernia surgery. An inguinal hernia is a condition where tissue pushes through a weak spot in the groin area.
  • Must have adequate Finnish language literacy, meaning you can read and understand Finnish well enough to follow instructions and information related to the study.
  • The surgery must be unilateral, which means it is only on one side of the body.

Who cannot join the trial?

4 criteria

  • Patients who are not recovering from an inguinal hernia open surgery. An inguinal hernia is a condition where a part of the intestine pushes through a weak spot in the abdominal muscles.
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the clinical trial group specified for this study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Medial Transversus Abdominis Plane (TAP) Block

    is a type of regional anesthesia used to numb the nerves in the abdominal wall. This helps reduce pain during and after surgery, specifically for procedures like inguinal hernia repair. The TAP block is administered by injecting anesthetic near the nerves that supply the abdominal muscles.

  • Rectus Sheath (RS) Block

    is another form of regional anesthesia that targets the nerves located in the rectus sheath, which is the fibrous covering of the rectus abdominis muscle. This block is used to provide pain relief for surgeries involving the abdominal area, such as inguinal hernia surgery. It is often used in combination with other blocks to enhance pain control.

What is already known about the treatment

  • Medial Transversus Abdominis Plane (TAP) Block

    This is a form of regional anesthesia administered through an injection into the abdominal wall to numb the nerves supplying the abdominal area. It is currently being studied in clinical trials to evaluate its effectiveness in aiding recovery after open inguinal hernia surgery. The main therapeutic indication is to provide pain relief during and after surgical procedures involving the abdomen. The mechanism of action involves blocking the transmission of pain signals by numbing the nerves in the abdominal wall. It is classified as a regional anesthetic technique.

  • Rectus Sheath Block

    This is another type of regional anesthesia delivered via injection into the rectus sheath, which is a fibrous compartment of the abdominal wall. It is being investigated in clinical trials for its potential benefits in recovery following open inguinal hernia surgery. The primary therapeutic use is to alleviate pain associated with abdominal surgeries. The mechanism of action involves the interruption of pain signal transmission by anesthetizing the nerves within the rectus sheath. It falls under the category of regional anesthetic techniques.

Investigated diseases

Inguinal Hernia – An inguinal hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the abdominal muscles. This condition often results in a noticeable bulge, which can be painful, especially when coughing, bending over, or lifting heavy objects. Inguinal hernias are more common in men and can occur on one or both sides of the groin. The progression of an inguinal hernia can lead to increased discomfort and potential complications if left untreated. Surgery is often required to repair the hernia and prevent further issues. Recovery from open inguinal hernia surgery involves managing pain and monitoring for any postoperative complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513406-59-00Estimated enrolment200 patientsSponsorPirkanmaan hyvinvointialue

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