About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
PECS II block
Procedure/Surgerypectoral nerve block type II (PECS II): ultrasound guided plane block which is administered local analgesic between pectoserratal and interpectoral muscles
SAPB block
Procedure/SurgerySAPB Block: ultrasound guided plane block which is administered local analgesic into the plane between serratus anterior and intercostal muscles
Tumescent local anesthesia
Procedure/SurgeryTumescent Infiltration Group: Patients will receive standard tumescent infiltration by the surgical team.
Treatment groups
Trial 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.
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.
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).
Other outcomes
Incidence of Post-operative Nausea and Vomiting (PONV)
The presence or absence of nausea, vomiting, or the need for antiemetic medication will be monitored and recorded as a percentage or scale score.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: