NL-OMON28887CompletedPhase 4
Efficacy of Pectoral Nerve (PECS II) Block for Breast Conserving Surgery: A Prospective Randomized Controlled Trial
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- St. Antonius Hospital
- Enrollment
- 200
Study Overview
Brief Summary
/A
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Female gender. - Unilateral breast conserving surgery. - Written informed consent according to ICH/GCP and national regulations. - ASA (American Society of Anesthesiologists) Class I-III .
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study: - Women < 18 year old. - Bilateral surgery. - Bleeding disorder or coagulopathy. - Chest wall deformity or infection of injection site. - Another (additional) nerve block (such as TPVB or epidural anesthesia). - Oncoplastic breast conserving surgery. - Autologous or implant based breast reconstruction. - Known allergy for levobupivacaine or local anesthetics from the amide group. - Chronic use of analgesics / opiates preoperatively (> 12 weeks). - 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. - Other concurrent solid tumor.
Investigators
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