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ESP-PECS A prospective randomized study to evaluate the influence of regional anesthesia close to the chest wall on perioperative processes and the postoperative recovery of patients undergoing breast breast surgery

ESP-PECS A prospective randomized study to evaluate the influence of regional anesthesia close to the chest wall on perioperative processes and the postoperative recovery of patients undergoing breast breast surgery - ESP-PECS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034546
Enrollment
99
Registered
2024-07-11
Start date
2024-06-17
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

patients with simple mastectomy or skin-sparing mastectomy

Interventions

Group 1: general anesthesia (control group) Group 2: general anesthesia + regional anesthesia, i.e. Pectoralis nerve and serratus plane nerve blocks (PECS II) Group 3: general anesthesia + regional an

Sponsors

Charité - Universitätsmedizin Berlin, Klinik für Gynäkologie mit Brustzentrum
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - written consent; - ASA I-III; - elective procedure N5: prophylactic ablatio simplex and/or skin-sparing mastectomy

Exclusion criteria

Exclusion criteria: - ASA IV and V - BMI >40 kg/m2 - Patients with emergency interventions (N4 +) - Refusal to participate in the study - Hypersensitivity to local anesthetics - Contraindication to one of the analgesia procedures - Previous scoliosis operations - Chronic pain patient - Presence of myasthenia gravis - Alcohol abuse - Lack of willingness to store and pass on pseudonymized medical data as part of the study - Patient is institutionalized by court or official order or currently unable to give consent

Design outcomes

Primary

MeasureTime frame
Quality of recovery (QoR-15GE)

Secondary

MeasureTime frame
perioperative processes; total dose of opioids administered postoperatively (cumulative morphine equivalents); health-related quality of life (PROMIS-33); quality of life (QLQ-C30); quality of life in breast cancer (QLQ-BR23); pain (subscales from the German pain questionnaire); overall patient satisfaction with pain therapy; intraoperative complications according to ClassIntra; postoperative complications according to Clavien-Dindo

Countries

Germany

Contacts

Public ContactMaria Margarete Karsten

Charité - Universitätsmedizin Berlin, Klinik für Gynäkologie mit Brustzentrum

esp-pecs-studie@charite.de+49 30 450 664364

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026