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Recruiting NCT07541040

Serratus vs ESP Block for Postoperative Pain in Unilateral Breast Surgery

No phase Interventional Post Operative Pain Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serratus Posterior Superior Intercostal Plane Block.
Who it may be relevant to
Registry conditions: Post Operative Pain, Opioid Use. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block for Postoperative Analgesia in Unilateral Breast Surgery: A Prospective, Randomized, Assessor-Blinded Trial

Overview

This prospective, randomized, assessor-blinded trial compares serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) for postoperative analgesia in unilateral breast surgery. 54 patients will be randomized to receive either SPSIPB or ESPB before general anesthesia. The primary outcome is postoperative pain scores within the first 24 hours. The secondary outcome is opioid consumption.

Detailed description

This prospective, randomized, assessor-blinded, single-center clinical trial is designed to compare the effects of serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery. Eligible adult female patients will be randomly assigned in a 1:1 ratio to receive either SPSIPB or ESPB under ultrasound guidance prior to induction of general anesthesia.

All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time points within the first 24 hours, both at rest and during movement. The primary outcome is postoperative pain scores within 24 hours. The secondary outcome is total opioid consumption during the same period.

This study aims to determine whether SPSIPB provides comparable or superior analgesia compared to ESPB in unilateral breast surgery.

Interventions

  • Procedure Serratus Posterior Superior Intercostal Plane Block
    An ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia.

Primary outcome measures

  • Postoperative Pain Scores (NRS) [Time frame: T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively]
Secondary outcome measures (1)
  • Total Opioid Consumption [Time frame: T0-T1: 0-1 hour, T1-T2: 1-4 hours, T2-T3: 4-8 hours, T3-T4: 8-12 hours, and T4-T5: 12-24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Female patients aged 18-65 years
  • ASA physical status I-III
  • Body mass index (BMI) between 18 and 35 kg/m²
  • Scheduled for elective unilateral breast surgery (mastectomy with or without sentinel lymph node biopsy)
  • Ability to understand and provide written informed consent

Exclusion criteria

  • Infection at the site of block application
  • Known allergy to local anesthetics
  • Coagulopathy or anticoagulant therapy
  • Chronic opioid use
  • Pregnancy
  • Inability to communicate or cooperate
  • Refusal to participate
  • Failed block
  • Requirement of additional intraoperative analgesia outside the study protocol
  • Development of serious intraoperative complications

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • University of Health Sciences Kocaeli City Hospital — İzmit

Publications

  • Arik E, Zengin M, Seker G, Kucuk O, Gungordu E, Ozguner Y, Alagoz A, Ergil J. Is the serratus posterior superior intercostal plane block a viable alternative to the erector spinae plane block for postoperative analgesia in breast surgery? A prospective, randomized trial. BMC Anesthesiol. 2025 Nov 29;26(1):11. doi: 10.1186/s12871-025-03531-y. PMID 41318393

Identifiers

NCT: NCT07541040 · KSH-ANREA-EC-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗