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

N/ANot Yet RecruitingNCT07811323

Gaziantep City Hospital60 enrolled

Overview

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.

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 and support early recovery, but no single technique has been established as the standard for breast reduction surgery. Two approaches are used routinely at the investigators' institution: ultrasound-guided pectoral nerve block type II (PECS II) with long-acting local anesthetic, and surgeon-administered local anesthetic wound infiltration. This is a single-center, prospective observational study in patients aged 18-70 years (ASA I-III) scheduled for elective reduction mammoplasty. Both analgesic techniques are part of routine clinical care; no additional intervention, drug, or procedure is applied for study purposes, and the choice of technique is made by the clinical team independently of the study. 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, incidence and severity of postoperative nausea and vomiting, and length of hospital stay (secondary outcomes). 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.

Study Type

INTERVENTIONAL

Interventions

PECS II blockPROCEDURE

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

SAPB blockPROCEDURE

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

Tumescent local anesthesiaPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to 24 hours post-operatively.

Secondary Outcomes

Quality of Recovery-15 (QoR-15) Score

The QoR-15 is a validated 15-item patient-reported questionnaire used to assess the quality of post-operative recovery. It evaluates five dimensions of health: emotional state, physical comfort, psychological support, physical independence, and pain. Each item is scored on a 0-10 scale, yielding a total score ranging from 0 (poor recovery) to 150 (excellent recovery). Higher scores indicate better quality of recovery.

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

Post-operative Pain Intensity (NRS Scores)

Assessment of post-operative pain using the 11-point Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst imaginable pain." Pain scores will be recorded both at rest and during movement (e.g., arm abduction).

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