The Quest for Opioid-Free Analgesia in Reduction Mammoplasty: A Comparative Analysis of PECS, SAP Blocks, and Tumescent Infiltration

NCT07811323 · tracked via the Priya Life Science Turkey tracker

Sponsor

Gaziantep City Hospital

Phase

Not applicable

Started

2027-01-15

Last updated

2026-09-14

Condition(s) studied

Breast SurgeryMammaplasty

Investigational drug(s) / intervention(s)

PECS II blockSAPB blockTumescent local anesthesia

PECS II block: pectoral nerve block type II (PECS II): ultrasound guided plane block which is administered local analgesic between pectoserratal and interpectoral muscles

SAPB block: SAPB Block: ultrasound guided plane block which is administered local analgesic into the plane between serratus anterior and intercostal muscles

Tumescent local anesthesia: Tumescent Infiltration Group: Patients will receive standard tumescent infiltration by the surgical team.

Study summary

Reduction mammoplasty is associated with significant early postoperative pain due to the extent of the incision and glandular resection. Effective regional analgesia may reduce opioid requirements; ultrasound-guided pectoral nerve block type II (PECS II), serratus anterior plane block (SAPS) and surgeon-administered local anesthetic wound infiltration.

This is a multi-center, prospective observational study in patients aged 18-70 years (ASA I-III) scheduled for elective reduction mammoplasty. The investigators will compare the two routinely applied techniques with respect to perioperative opioid consumption (primary outcome), postoperative pain scores on the Numeric Rating Scale, total rescue analgesic dose within the first 24 postoperative hours. A minimum of 58 patients will be enrolled based on a priori power analysis. The aim is to determine which of the two existing analgesia protocols better minimizes postoperative analgesic consumption and supports early recovery, in order to inform future pain management protocols.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Patients scheduled for elective oncoplastic or reconstructive reduction mammoplasty surgery. * Patients aged between 18 and 70 years.American Society of Anesthesiologists (ASA) physical status classification I, II, or III. * Patients who voluntarily agree to participate and sign the informed consent form. Exclusion Criteria: * Patient refusal to participate in the study or to receive regional anesthesia. * Active localized infection at the site of the proposed block or surgical area. * Coagulopathy, bleeding disorders, or patients on active anticoagulant therapy. * Psychiatric or cognitive disorders that prevent the understanding of the NRS or QoR-15 scoring systems. * History of revision breast surgery or emergency procedures.

Primary outcome measure(s)

Total Post-operative Opioid Consumption — Up to 24 hours post-operatively.
The total amount of opioid analgesics (converted to intravenous morphine equivalents in milligrams) consumed by the patient via patient-controlled analgesia (PCA) or rescue medication.

Trial sites (1)

Facility	City	Region	Status
Gaziantep City Hospital	Gaziantep	şahinbey

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07811323 on ClinicalTrials.gov ↗ ← All trials in Turkey