Study on Pain Relief for Patients with Inguinal Hernia: Comparing Ropivacaine Hydrochloride TAP Block and Sodium Chloride Local Infiltration

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What is this study about?

This clinical trial is focused on studying the pain management techniques for patients undergoing surgery for an inguinal hernia, which is a condition where a part of the intestine protrudes through a weak spot in the abdominal muscles. The study will compare two methods of pain relief: a technique called a TAP block and local infiltration at the surgical site. A TAP block involves injecting a pain-relieving medication into the abdominal wall to block pain signals, while local infiltration involves injecting medication directly at the site of surgery.

The medications used in this study include Ropivacaine Fresenius Kabi 7.5 mg/1 ml Solution injectable, which contains the active ingredient ropivacaine hydrochloride, and NaCl 0.9% B. Braun, oplossing voor injectie, which contains sodium chloride. These medications are administered through injection. The purpose of the study is to determine if the TAP block provides better pain relief than the local infiltration method.

Participants in the study will undergo their scheduled laparoscopic inguinal hernia repair surgery and will receive one of the two pain management techniques. The study will monitor the effectiveness of pain relief and the need for additional pain medication after surgery. The trial aims to find out which method offers superior pain control, potentially improving recovery experiences for patients undergoing this type of surgery.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age between 18 and 80 years, and undergoing a laparoscopic inguinal hernia repair operation.

2 preparation for surgery

Before the surgery, preparation involves understanding the procedure and the analgesic techniques being compared: the TAP block and local infiltration at the surgical site.

3 administration of analgesic

During the surgery, one of two analgesic methods is used. The first method is the TAP block, which involves injecting a solution containing ropivacaine hydrochloride and sodium chloride into the abdominal wall. The second method is local infiltration, where the same solution is injected directly at the surgical site.

4 postoperative care

After the surgery, pain levels are monitored using a numerical rating scale (NRS). The primary goal is to observe a difference in pain scores between the two methods.

The secondary goal is to assess the reduction in the need for additional pain relief after using either the TAP block or local infiltration.

5 follow-up

Follow-up involves regular assessments to evaluate the effectiveness of the analgesic method used and to ensure recovery is progressing as expected.

Who Can Join the Study?

Patients must have an inguinal hernia, which is a condition where a part of the intestine or fat pushes through a weak spot in the lower belly area.
Patients should be classified as ASA I to III. This means they are in a health status group ranging from healthy (I) to having mild to severe systemic disease (III), according to the American Society of Anesthesiologists.
Patients must be between 18 and 80 years old.
Patients must be scheduled to have a laparoscopic inguinal hernia repair operation, which is a minimally invasive surgery to fix the hernia.
Both female and male patients can participate.

Who Cannot Join the Study?

Patients with a history of allergies to local anesthetics cannot participate. Local anesthetics are medicines used to numb a specific area of the body.
Individuals with bleeding disorders are excluded. Bleeding disorders are conditions that affect the way your blood normally clots.
Patients who have had previous abdominal surgery are not eligible. Abdominal surgery refers to any surgical procedure involving the abdomen, which is the area of the body between the chest and the pelvis.
People with severe liver or kidney disease cannot take part. The liver and kidneys are important organs that help filter and clean the blood.
Pregnant or breastfeeding women are excluded from the study. Pregnancy and breastfeeding involve carrying a baby in the womb and feeding a baby with milk from the breast, respectively.
Individuals with a body mass index (BMI) over 35 are not eligible. BMI is a measure that uses your height and weight to work out if your weight is healthy.
Patients who are unable to give informed consent cannot participate. Informed consent means understanding the details of the study and agreeing to take part.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
AZ Rivierenland	Rumst	Belgium
Vrije Universiteit Brussel	Jette	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	31.01.2025

Trial locations

Investigated drugs:

TAP Block is a type of regional anesthesia technique used to numb the abdominal area. In this trial, it is being tested to see if it provides better pain relief for patients undergoing laparoscopic inguinal hernia repair compared to other methods.

Local Infiltration involves the injection of anesthetic directly at the surgical site by the surgeon. This method is being compared to the TAP block to evaluate its effectiveness in managing pain after the surgery.

Investigated diseases:

Inguinal hernia

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 presents as a bulge in the groin area, which may become more noticeable when standing up or coughing. It can cause discomfort or pain, especially during physical activities or lifting heavy objects. Over time, the hernia may increase in size and lead to more pronounced symptoms. In some cases, the hernia can become trapped, leading to more severe symptoms. Regular monitoring and medical evaluation are important to manage the condition effectively.

Trial ID:

2024-515759-39-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pain Relief for Patients with Inguinal Hernia: Comparing Ropivacaine Hydrochloride TAP Block and Sodium Chloride Local Infiltration

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?