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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515183-30-00
Acronym
NL83450.100.23
Enrollment
130
Registered
2024-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative and chronic pain after breast cancer surgery

Brief summary

Postoperative NRS pain scores in the breast.

Detailed description

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).

Interventions

DRUGEXPAREL liposomal 133 mg/10 mL prolonged-release dispersion for injection
DRUGBupivacaïne Eugia 5 mg/ml
DRUGoplossing voor injectie

Sponsors

St. Antonius Ziekenhuis
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Postoperative NRS pain scores in the breast.

Secondary

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026