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NCT Number: NCT07674836

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Kocaeli City Hospital

İzmit, Kocaeli, 41200, Turkey (Türkiye)

Location contact

Engin Çetin, M.D

CONTACT

[email protected]

05321206004 ext. 90

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serratus Posterior Superior Intercostal Plane Block

Procedure

An ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia.

Other names: SPSIPB

Ultrasound-Guided Erector Spinae Plane Block

Procedure

An ultrasound-guided erector spinae plane block performed prior to induction of general anesthesia using 30 mL of 0.25% bupivacaine.

Other names: ESPB

Primary outcomes

  1. Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form

    Time frame: Time Frame: T0: 3 months postoperatively

    Chronic postoperative pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF assesses pain severity (worst, least, average, and current pain) and pain interference with daily activities. Pain severity items are scored on a 0-10 numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Pain interference items are scored on a 0-10 numeric rating scale (0 = does not interfere; 10 = completely interferes). Higher scores indicate worse pain severity and greater pain-related interference.

Secondary outcomes

  1. Neuropathic Pain Assessed by the DN4 Questionnaire

    Time frame: T0: 3 months postoperatively

    Neuropathic pain will be assessed using the Douleur Neuropathique 4 Questions (DN4) questionnaire. The DN4 consists of 10 items with a total score ranging from 0 to 10 (0 = no neuropathic pain characteristics; 10 = all neuropathic pain characteristics present). Higher scores indicate a greater likelihood of neuropathic pain. A total score of 4 or higher is considered indicative of neuropathic pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Engin Çetin, M.D

CONTACT

[email protected]

05321206004 ext. 90

Engin Çetin, M.D.

CONTACT

[email protected]

05321206004 ext. 90

Sponsors and collaborators

Lead sponsor

Engin Çetin

Other Gov

Registry information

Official study 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

Acronym: SPES-CPSP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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