2024-515183-30-00RecruitingPhase 3
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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- St. Antonius Ziekenhuis
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Postoperative NRS pain scores in the breast.
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Unilateral mastectomy.
- •Written informed consent according to ICH/GCP and national regulations.
- •ASA (American Society of Anesthesiologists) Class I-III.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Postoperative NRS pain scores in the breast.
Postoperative NRS pain scores in the breast.
Secondary Outcomes
- Postoperative NRS pain scores in the axilla.
- Intraoperative need of opiates (milligrams).
- Postoperative need of opiates or other pain killers (milligrams).
- Patient-reported chronic (> 12 weeks) pain (yes/no).
- Patient satisfaction, measured by the BREAST-Q BCT.
- Postoperative time that patients need to be observed in the recovery room (minutes).
- Time until patients are discharged from the hospital (hours).
- Use of additional anti-emetics for PONV (yes/no).
- Vomiting (yes/no).
- Complications (wound infection rate, hematoma, abscess, pneumothorax, local anesthesia systemic toxicity).
Investigators
PhD candidate
Scientific
St. Antonius Ziekenhuis
Study Sites (2)
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