Study on the Effectiveness of Ropivacaine Hydrochloride, Anhydrous Lidocaine Hydrochloride, and Alfentanil for Patients Undergoing Minor Breast Cancer Surgery

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What is this study about?

This clinical trial is focused on studying the effectiveness of a specific pain relief method called the intertransverse process block for patients undergoing minor surgery for breast cancer. The trial involves the use of different medications to manage pain during the surgery. The main medication being tested is Ropivacaine, which is a local anesthetic used to numb a specific area of the body. Additionally, the study will also involve the use of Lidocaine and Alfentanil, which are other types of medications used for pain relief.

The purpose of the study is to determine how effective the intertransverse process block is in providing pain relief during minor breast cancer surgery. Participants in the study will receive either a single or multiple injections of the anesthetic to see which method provides better pain control. The study will monitor the number of areas on the body that become numb, as well as other factors like changes in skin temperature and blood pressure. The trial will also evaluate how patients rate their pain relief experience.

Throughout the study, participants will be closely monitored to ensure their safety and to gather data on the effectiveness of the pain relief methods being tested. The trial aims to provide valuable information that could improve pain management techniques for patients undergoing similar surgical procedures in the future.

1 joining the study

Upon joining the study, you will have already received detailed information about the trial and signed the informed consent form. This confirms your understanding and agreement to participate.

2 preparation for surgery

You will be scheduled for a day case elective unilateral minor breast cancer surgery. This means the surgery is planned and you will be able to go home the same day.

3 administration of medication

Before the surgery, you will receive a local injection of a medication called ropivacaine hydrochloride or anhydrous lidocaine hydrochloride. This is to help block pain in the area where the surgery will take place.

The medication will be administered as a solution for injection and may be given through different routes such as subcutaneous (under the skin) or intravenous (into a vein).

4 surgery

The surgery will be performed as planned. The main objective is to determine the effectiveness of the intertransverse process block, which is a technique used to manage pain during and after the surgery.

5 post-surgery evaluation

After the surgery, the number of areas (thoracic dermatomes) that are numb will be assessed. This is the primary outcome of the study.

Additional evaluations will include sensory mapping to measure the spread of numbness, checking temperature differences between the treated and untreated sides, monitoring changes in blood pressure, and assessing pain levels using a numeric rating scale.

6 completion of the trial

Once all evaluations are completed, your participation in the trial will conclude. You will receive any necessary follow-up care as per the standard medical procedures.

Who Can Join the Study?

Patients must be scheduled for a planned, same-day surgery for one side of the breast due to minor breast cancer, including a condition called DCIS.
Patients must be 18 years or older at the time they join the study.
Patients must be classified as ASA class I-III. This is a system used by doctors to assess the physical health of patients before surgery, where I means healthy and III means severe systemic disease.
Patients must have received detailed information about the study both verbally and in writing, and must have signed the “Informed Consent” form, which means they agree to participate in the study.
Patients must weigh more than 52.5 kilograms. This is important because the study involves a medication called Ropivacaine, and the dose is based on weight.

Who Cannot Join the Study?

Patients who are not diagnosed with breast cancer cannot participate.
Only female patients are eligible; male patients cannot participate.
Patients who are considered part of a vulnerable population are not eligible. This means individuals who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Zealand University Hospital	Koege	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	15.09.2022

Trial locations

Investigated drugs:

The clinical trial is focused on evaluating the effectiveness of a specific type of pain relief method called the intertransverse process block. This method is used to manage pain during minor breast cancer surgery. The intertransverse process block involves injecting a local anesthetic near the spine to block pain signals from reaching the brain. This technique aims to provide pain relief during and after the surgery, potentially reducing the need for other pain medications.

Investigated diseases:

Breast cancer

Breast cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby tissues and lymph nodes. The cancerous cells can invade surrounding breast tissue and form a mass or lump. Over time, the disease may spread to other parts of the body through the lymphatic system or bloodstream. The progression of breast cancer varies depending on the type and stage of the disease.

Trial ID:

2022-501312-34-00

Protocol code:

ZUH-ITP-MBCS

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Ropivacaine Hydrochloride, Anhydrous Lidocaine Hydrochloride, and Alfentanil for Patients Undergoing Minor Breast Cancer Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?