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Recruiting NCT07674836

SPSIP Block Versus ESP Block for Chronic Pain After Unilateral Breast Surgery

No phase Interventional Postoperative 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, Ultrasound-guided Erector Spinae Plane Block.
Who it may be relevant to
Registry conditions: Postoperative 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 the Prevention of Chronic Postoperative Pain After Unilateral Breast Surgery: A Prospective, Randomized, Assessor-Blinded Trial

Overview

This prospective, randomized, assessor-blinded study will compare serratus posterior superior intercostal plane block and erector spinae plane block in adult female patients undergoing unilateral breast surgery. The primary outcome is chronic postoperative pain at 3 months, assessed using the Brief Pain Inventory-Short Form.

Detailed description

This single-center, prospective, randomized, controlled, assessor-blinded study will include adult female patients scheduled for elective unilateral breast surgery. Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block or erector spinae plane block before general anesthesia.

The study aims to compare the effects of these two regional anesthesia techniques on chronic postoperative pain at 3 months. Chronic pain will be assessed using the Brief Pain Inventory-Short Form.

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.
  • Procedure Ultrasound-guided Erector Spinae Plane Block
    An ultrasound-guided erector spinae plane block performed prior to induction of general anesthesia using 30 mL of 0.25% bupivacaine.

Primary outcome measures

  • Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form [Time frame: Time Frame: T0: 3 months postoperatively]
Secondary outcome measures (1)
  • Neuropathic Pain Assessed by the DN4 Questionnaire [Time frame: T0: 3 months 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

Identifiers

NCT: NCT07674836 · KSH-ANREA-EC-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗