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

NCT07811323 | Not Yet Recruiting

• 1 other identifier: 2026/206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Surgery; Mammaplasty

Keywords

PECsII block; SAPs block; Reduction mammoplasty; breast reduction

Outcome Measures

Primary Outcomes (1)

• Total Post-operative Opioid Consumption

  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.

  Up to 24 hours post-operatively.

Secondary Outcomes (2)

• Quality of Recovery-15 (QoR-15) Score

  Baseline (pre-operatively) and at 24 hours post-operatively.

• Post-operative Pain Intensity (NRS Scores)

  At post-operative 1st, 2nd, 4th, 6th, 12th, and 24th hours.

Other Outcomes (1)

• Incidence of Post-operative Nausea and Vomiting (PONV)

  Up to 24 hours post-operatively.

Study Arms (1)

Reduction Mammoplasty

ACTIVE COMPARATOR

Reduction mammoplasty, also known as breast reduction, is a surgical procedure that removes excess breast tissue, fat, and skin to reduce breast size and weight. It aims to alleviate physical symptoms like chronic back and neck pain while reshaping the breasts to improve the patient's quality of life.

Procedure: PECS II block; Procedure: SAPB block; Procedure: Tumescent local anesthesia

Interventions

PECS II block PROCEDURE

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

Reduction Mammoplasty

SAPB block PROCEDURE

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

Reduction Mammoplasty

Tumescent local anesthesia PROCEDURE

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

Reduction Mammoplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only female patients undergoing elective reconstruction breast surgery are included in this study to maintain sample homogeneity, as the incidence of breast reconstruction in male patients is extremely low.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Study Sites (1)

Gaziantep City Hospital

Gaziantep, şahinbey, 27072, Turkey (Türkiye)

Location

Related Publications (2)

• Wallace CC, Wetzel ME, Howell C, Vasconez HC. The Efficacy of Pectoralis Nerve Blockade in Breast Reductions: A Prospective Randomized Trial. Ann Plast Surg. 2021 Jun 1;86(6S Suppl 5):S632-S634. doi: 10.1097/SAP.0000000000002763.

  PMID: 33625027 RESULT

• Kerrigan CL, Collins ED, Striplin D, Kim HM, Wilkins E, Cunningham B, Lowery J. The health burden of breast hypertrophy. Plast Reconstr Surg. 2001 Nov;108(6):1591-9. doi: 10.1097/00006534-200111000-00024.

  PMID: 11711933 RESULT

Central Study Contacts

Gamze Nur Teke, medical doctor

CONTACT

+905546694389; gamzenur.koca@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Doctor

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)