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Clinical Trials/EUCTR2019-004039-21-NL
EUCTR2019-004039-21-NL
Active, not recruiting
Phase 1

Efficacy of Pectoral Nerve (PECS II) Block for Breast Conserving Surgery: A Prospective Randomized Controlled Trial - CONPECSII

St Antonius Hospital0 sites130 target enrollmentJanuary 21, 2020
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ConditionsBreast cancerPECSII blockBreast conserving surgeryLumpectomyTherapeutic area: Diseases [C] - Cancer [C04]
DrugsChirocaine 1,25 mg/ml, oplossing voor infusie

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Breast cancerPECSII blockBreast conserving surgeryLumpectomy
Sponsor
St Antonius Hospital
Enrollment
130
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 21, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion 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 .
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 130
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 130

Exclusion Criteria

  • •\- 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).

Outcomes

Primary Outcomes

Not specified

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