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Study on Reducing Postoperative Pain in Breast Surgery Patients Using Lidocaine Hydrochloride Injection

Verified siteRegistered 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 reducing pain after breast surgery. The study is investigating the use of a local anesthetic called lidocaine, specifically in the form of lidocaine hydrochloride injection. The aim is to see if injecting lidocaine at the site of the surgical scar can help prevent acute pain that often occurs after surgery.

The purpose of the study is to demonstrate that using lidocaine during surgery can decrease the need for pain relief medications, especially opioids, which are strong painkillers. Participants in the study will receive an injection of lidocaine at a concentration of 0.5% during their breast surgery. The study will monitor the level of pain experienced by participants at various times after the surgery, such as 1, 4, 12, 24, and 48 hours later.

The study will help understand if lidocaine can effectively reduce the incidence of acute postoperative pain, making recovery more comfortable for patients undergoing breast surgery. The trial is expected to continue until 2026, providing valuable insights into pain management for surgical patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after signing the informed consent form. Eligibility requires being a woman over 18 years old, diagnosed with malignant breast neoplasm, and scheduled for surgery.
Step 2
Surgery preparation
Before surgery, preparation includes standard preoperative procedures. No specific trial-related actions are required at this stage.
Step 3
Administration of <b>lidocaine</b>
During surgery, a local anesthetic called lidocaine hydrochloride is injected at a concentration of 0.5% into the surgical incision area. This is done to help prevent acute pain after the operation.
Step 4
Postoperative pain assessment
Pain levels are assessed at 1, 4, 12, 24, and 48 hours after surgery. This is done using a visual analog scale (VAS), both at rest and during arm movement above 90 degrees.
Step 5
Monitoring and follow-up
Regular monitoring continues to evaluate the need for additional pain relief, especially the use of opioids. The goal is to reduce the requirement for these medications.

Who can join the trial?

5 criteria

The patient must be a woman.
The patient must be over 18 years old.
The patient must have been diagnosed with breast cancer.
The patient must be a candidate for planned surgical treatment at the specified medical center.
The patient must have signed the informed consent, which is a document that explains the study and confirms the patient's agreement to participate.

Who cannot join the trial?

2 criteria

Only women can participate in this study. Men are not eligible.
Participants must not belong to any vulnerable population. This means people who might need special protection or care, like children or those unable to make decisions for themselves, cannot join.

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Verified sites

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Verified
Hospital General Hospitalet
L'hospitalet De Llobregat, Spain

Trial locations

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Investigated drugs

Lidocaine is a local anesthetic used in this trial to reduce acute postoperative pain associated with breast surgery. It is injected directly into the surgical incision area during the operation. The goal is to decrease the need for pain relief medications, especially opioids, after the surgery.

Lidocaine Hydrochloride

What is already known about the treatment

Lidocaine – Lidocaine is administered as an injection directly into the surgical incision site. It is currently being studied for its effectiveness in reducing acute postoperative pain following breast surgery. The main therapeutic use of lidocaine in this context is to decrease the need for postoperative pain relief, particularly reducing the use of opioids. At the molecular level, lidocaine works by blocking sodium channels in nerve cells, which prevents the transmission of pain signals. It is classified as a local anesthetic.

Investigated diseases

Postoperative Pain – This condition refers to the pain experienced by patients following surgical procedures. It typically arises due to tissue damage and inflammation caused by the surgery. The intensity of postoperative pain can vary depending on the type and extent of the surgery. It often manifests as acute pain, which can be felt at rest or during movement, such as when lifting the arm after breast surgery. The pain usually peaks shortly after the operation and gradually decreases as the healing process progresses. Managing this pain is crucial to ensure patient comfort and facilitate recovery.