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Study on Pain Relief After Breast Cancer Surgery: Comparing Liposomal Bupivacaine and Levobupivacaine in Patients Undergoing Mastectomy

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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 studying pain management after breast cancer surgery, specifically for patients undergoing a mastectomy. The study aims to compare the effectiveness of two different pain relief treatments: a long-acting form of bupivacaine called EXPAREL, and another medication called levobupivacaine. Both medications are used to block pain in the chest area, known as a Pectoral Nerve Block or PECS II Block, which is administered before surgery.

The purpose of the study is to determine if patients experience less pain after surgery when they receive the PECS II Block with liposomal bupivacaine compared to levobupivacaine. The trial will involve patients who are having a single breast removed due to cancer. Participants will receive one of the two medications before their surgery, and their pain levels will be monitored after the procedure. The study will also look at other factors such as the need for additional pain medication, patient satisfaction, and any complications that may arise.

Throughout the study, patients will be observed to see how long they need to stay in the recovery room and when they can be discharged from the hospital. The trial will also assess if patients experience any long-term pain or require additional treatments for nausea and vomiting after surgery. The goal is to find the most effective way to manage pain and improve recovery for patients undergoing breast cancer surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written informed consent, confirming understanding of the study and agreement to participate.

    Eligibility includes undergoing a unilateral mastectomy and being classified as ASA Class I-III, which refers to a scale used to assess the physical status of patients before surgery.

  2. Step 2

    Preoperative preparation

    Before surgery, a Pectoral Nerve (PECS II) Block is administered. This involves an injection to numb the area around the breast to reduce pain after surgery.

    Two types of medication may be used for this block: liposomal bupivacaine or levobupivacaine. The choice of medication is determined by the study protocol.

  3. Step 3

    Surgery

    The mastectomy surgery is performed. The PECS II Block aims to manage pain during and after the procedure.

  4. Step 4

    Postoperative care

    After surgery, pain levels are monitored using a scale called the NRS (Numeric Rating Scale), which helps assess pain intensity in the breast and axilla (underarm area).

    The need for additional pain relief, such as opiates or other painkillers, is evaluated and provided as necessary.

  5. Step 5

    Recovery and observation

    Time spent in the recovery room is recorded, along with any additional medications needed for nausea or vomiting.

    The duration of hospital stay is monitored, and discharge occurs when recovery criteria are met.

  6. Step 6

    Follow-up

    Long-term outcomes, such as chronic pain and patient satisfaction, are assessed. Satisfaction is measured using a questionnaire called the BREAST-Q BCT.

    Any complications, such as infection or other issues, are documented and addressed.

Who can join the trial?

5 criteria

  • Must have had a unilateral mastectomy, which means surgery to remove one breast.
  • Must provide written informed consent, which is a document you sign to show you understand the study and agree to participate.
  • Must be classified as ASA Class I-III, which refers to a health status classification by the American Society of Anesthesiologists. It means you are healthy or have mild to severe systemic disease.
  • Must be a female participant.
  • Must be within the age range of 18 to 64 years old.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing postoperative (after surgery) or chronic pain (long-lasting pain) after breast cancer surgery cannot participate.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are considered part of a vulnerable population (groups that may need special protection) are not eligible.
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Investigated drugs

  • Liposomal Bupivacaine

    is a long-acting form of bupivacaine that is used to manage pain after surgery. In this trial, it is administered as part of a Pectoral Nerve (PECS II) Block before mastectomy surgery. The goal is to see if it can reduce pain in the breast area after the surgery.

  • Levobupivacaine

    is another type of local anesthetic used to numb the area and manage pain. It is also given as part of a PECS II Block before mastectomy surgery. This trial compares its effectiveness in reducing postoperative pain to that of liposomal bupivacaine.

What is already known about the treatment

  • Liposomal Bupivacaine

    This medication is administered via injection as part of a nerve block technique, specifically the Pectoral Nerve (PECS II) Block, to manage postoperative and chronic pain following breast cancer surgery. It is currently being studied in clinical trials to evaluate its effectiveness compared to other local anesthetics. The main therapeutic indication is pain relief after mastectomy surgery. Liposomal bupivacaine works by slowly releasing bupivacaine, a local anesthetic, over an extended period, blocking nerve signals that transmit pain. It is classified as a long-acting local anesthetic.

  • Levobupivacaine

    This medication is also administered via injection for nerve block procedures, such as the PECS II Block, to alleviate pain after breast cancer surgery. It is being compared in clinical trials to liposomal bupivacaine to determine its efficacy in reducing postoperative pain. The primary use is for pain management following mastectomy. Levobupivacaine functions by inhibiting nerve signal transmission, providing pain relief. It belongs to the pharmacological class of local anesthetics.

Investigated diseases

  • Postoperative Pain

    This condition occurs after surgical procedures, such as breast cancer surgery, and is characterized by discomfort or pain in the area where the surgery was performed. The pain can vary in intensity and may be influenced by factors such as the type of surgery and individual pain tolerance. It typically begins immediately after the operation and can last for several days or weeks. The pain may be sharp, throbbing, or aching and can affect the patient's ability to move and perform daily activities. Over time, the pain usually decreases as the body heals, but in some cases, it can persist and become chronic.

  • Chronic Pain After Breast Cancer Surgery

    This condition refers to persistent pain that lasts for more than 12 weeks following breast cancer surgery. It can occur even after the surgical wounds have healed and may be due to nerve damage or other factors related to the surgery. The pain can be continuous or intermittent and may be described as burning, shooting, or stabbing. It can significantly impact a person's quality of life, affecting sleep, mood, and physical function. The exact cause of chronic pain after surgery is not always clear, and it may require ongoing management to alleviate symptoms.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515183-30-00Protocol codeNL83450.100.23Estimated enrolment130 patientsSponsorSt Antonius Hospital

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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