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

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What is this study about?

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.

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 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 surgery

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

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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Gelre Hospitals	Zutphen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	19.10.2023

Trial locations

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.

Investigated diseases:

Procedural pain

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 ID:

2024-515183-30-00

Protocol code:

NL83450.100.23

Trial Phase:

Therapeutic confirmatory (Phase III)

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