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Study on Pain Relief After Breast Cancer Surgery Using Ropivacaine Hydrochloride and Alfentanil in Healthy Volunteers

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 evaluating a method called the intertransverse process block, which is primarily used to help reduce pain after breast cancer surgery. The study involves two medications: Ropivacaine and Alfentanil. Ropivacaine is a local anesthetic, which means it numbs a specific area of the body to prevent pain during procedures. Alfentanil is a type of pain medication that is often used during surgeries to help manage pain.

The purpose of the study is to determine how effective the intertransverse process block is in managing pain. Participants in the study will receive either a single or multiple injections of the medications. The study will observe how well the block works by measuring the number of areas on the body that become numb, as well as other factors like changes in skin temperature and blood pressure. Participants will also be asked about their satisfaction with the pain relief they experience.

The study is designed to be a crossover trial, which means that participants will receive both types of injections at different times. This allows researchers to compare the effects of single versus multiple injections in the same individuals. The trial is conducted with healthy volunteers to ensure the safety and effectiveness of the procedure before it is used more widely in patients undergoing breast cancer surgery.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, participants will attend an initial visit. During this visit, participants will receive detailed information about the study and will be asked to sign an informed consent form, confirming their understanding and willingness to participate.

    Participants will undergo a brief health assessment to ensure they meet the study's eligibility criteria, which include being male, aged 18 or older, and having a weight greater than 52.5 kilograms.

  2. Step 2

    First procedure

    Participants will receive the first intertransverse process block, which is a type of pain relief procedure. This involves the administration of a medication called ropivacaine hydrochloride through a local injection.

    The purpose of this procedure is to assess the number of thoracic dermatomes, which are areas of the skin supplied by nerves, that become anesthetized.

  3. Step 3

    Sensory mapping

    After the first procedure, participants will undergo sensory mapping. This involves measuring the extent of the sensory block, or the area of the skin that has lost sensation, in square centimeters.

    This step helps to evaluate the effectiveness of the block in terms of how far the numbness spreads.

  4. Step 4

    Thermography evaluation

    Participants will have a thermography evaluation, which measures temperature differences between the side of the body that received the block and the side that did not.

    This evaluation helps to understand the impact of the block on body temperature regulation.

  5. Step 5

    Blood pressure monitoring

    Non-invasive blood pressure will be monitored to observe any changes that occur as a result of the block.

    This monitoring is important to ensure the safety and well-being of participants during the study.

  6. Step 6

    Pain score assessment

    Participants will be asked to rate their satisfaction with the block application using a numeric rating scale for pain scores.

    This assessment provides valuable feedback on the comfort and effectiveness of the procedure from the participant's perspective.

  7. Step 7

    Second procedure

    Participants will undergo a second intertransverse process block procedure. This may involve a single or multiple injections, as determined by the study design.

    The second procedure allows for a comparison of the effects of different injection techniques.

  8. Step 8

    Follow-up assessments

    Following the second procedure, participants will repeat the sensory mapping, thermography evaluation, blood pressure monitoring, and pain score assessment.

    These follow-up assessments help to gather comprehensive data on the efficacy and safety of the block procedures.

Who can join the trial?

5 criteria

  • Must be male.
  • Must be 18 years or older at the time of joining the study.
  • Must be classified as ASA class I-II, which means having a normal healthy status or a mild systemic disease according to the American Association of Anesthesiologists.
  • Must have received detailed information about the study both verbally and in writing, and must have signed the "Informed Consent" form, which is a document that explains the study and confirms your agreement to participate.
  • Must weigh more than 52.5 kilograms (this is important because of the maximum safe dose of a medication called Ropivacaine).

Who cannot join the trial?

2 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable population refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Intertransverse Process Block is a type of pain relief technique used in this clinical trial. It involves injecting a local anesthetic near the spine, specifically between the transverse processes of the vertebrae. This method is designed to numb the nerves in that area, providing pain relief. The trial aims to determine how effective this technique is when performed as a single injection compared to multiple injections. Participants in the trial are healthy volunteers, and the study is focused on understanding the best way to use this block for pain management.

What is already known about the treatment

Intertransverse Process Block (ITP Block) – The Intertransverse Process Block is a method used to relieve pain, particularly after breast cancer surgery. It is administered through an injection, either as a single or multiple doses, into the area near the spine. Currently, this technique is being studied in clinical trials to assess its effectiveness in pain management. The ITP Block works by blocking nerve signals that transmit pain, providing relief to the patient. It is classified under pain management therapies and is being evaluated for its potential benefits in medical practice.

Investigated diseases

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 lymph nodes or other parts of the body. The growth of cancer cells can form a lump or mass in the breast. Over time, the cancer may invade surrounding tissues and organs. The progression can vary greatly among individuals, with some experiencing slow growth and others more rapid advancement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501312-34-01Protocol codeZUH-ITP-MBCSEstimated enrolment12 patientsSponsorRegion Sjaelland

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