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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Pirkanmaan hyvinvointialue Tampere Finland

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

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
01.09.2024

Trial locations

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.

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 ID:
2024-513406-59-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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

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

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