Efficacy of Pectoral Nerve (PECS II) Block with Liposomal Bupivacaine versus Levobupivacaine for Patients undergoing a Mastectomy: A Prospective Randomized Controlled Trial.

Efficacy of Pectoral Nerve (PECS II) Block with Liposomal Bupivacaine versus Levobupivacaine for Patients undergoing a Mastectomy: A Prospective Randomized Controlled Trial. - APECSII

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53831

Enrollment

130

Registered

2023-02-21

Start date

2023-10-23

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

Breast cancer mammacarcinoma

Interventions

One arm receives a pre-operative PECS II-block with liposomal Bupivacaine prior to mastectomy and the second arm receives a PECS II-block with Levobupivacaine.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Unilateral mastectomy - Written informed consent - Asa I-III

Exclusion criteria

Exclusion criteria: - Age 12 weeks) - Previous breast surgery ipsi- or contralateral less than 5 years prior to planned mastectomy (except diagnostic biospies) - Not able to speak or understand the Dutch language fluently - Pregnancy or breast feeding - Psychological, neurological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol

Design outcomes

Primary

Measure	Time frame
Postoperative (first 72 hours) NRS pain scores	—

Secondary

Measure	Time frame
- Postoperative painscores in the axilla - Intraoperative need of opiates - Postoperatieve need of opiates and other painkillers - Chronic pain (>12 weeks) - Satisfaction, measured by BREAST-Q mastectomy - Time to discharge - Postoperative nausea and vomiting (PONV)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)