BridgeMD
APECS II: Comparing the efficacy of Pectoral Nerve (PECS II) Block with long-acting liposomal bupivacaine versus levobupivacaine for Mastectomy Surgery: A Multicenter Prospective Randomized Controlled Trial
EU CTIS ID: 2024-515183-30-00
What this study is testing
To assess whether postoperative NRS pain scores in the breast after mastectomy is lower in patients who receive a preoperative PECS II block with liposomal bupivacaine than in patients who receive a preoperative PECS II block with levobupivacaine.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Unilateral mastectomy.
- Written informed consent according to ICH/GCP and national regulations.
- ASA (American Society of Anesthesiologists) Class I-III.
You likely can't join if
- Patients < 18 year old.
- Previous breast surgery ipsi- or contralateral (except diagnostic biopsies).
- Not able to speak or understand the Dutch language fluently.
- Palliative surgery.
- Metastatic disease.
- Pregnancy or breast feeding.
See the full eligibility criteria
- Unilateral mastectomy.
- Written informed consent according to ICH/GCP and national regulations.
- ASA (American Society of Anesthesiologists) Class I-III.
- Patients < 18 year old.
- Previous breast surgery ipsi- or contralateral (except diagnostic biopsies).
- Not able to speak or understand the Dutch language fluently.
- Palliative surgery.
- Metastatic disease.
- Pregnancy or breast feeding.
- Psychological, neurological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
- Bilateral surgery.
- Bleeding disorder or coagulopathy.
- Chest wall deformity or infection of injection site.
- Another (additional) nerve block (such as TPVB or epidural anesthesia).
- Autologous or implant based breast reconstruction.
- Known allergy for (levo)bupivacaine or local anesthetics from the amide group.
- Known allergy or contra-indication for NSAID.
- Chronic use of opiates preoperatively (> 12 weeks).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.