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RecruitingNCT07674836SPES-CPSPUpdated Sep 30, 2026

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

An interventional study of Serratus Posterior Superior Intercostal Plane Block and Ultrasound-guided Erector Spinae Plane Block in Postoperative Pain and Opioid Use, sponsored by Engin Çetin. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Engin Çetin · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Postoperative Pain
  • Opioid Use

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Keywords

  • Post Operative Pain
  • Opioid Use
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    SPSIP Block

    Participants will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia.

    Procedure: Serratus Posterior Superior Intercostal Plane Block

  • Active comparator
    ESPB Block

    Participants will receive an ultrasound-guided erector spinae plane block (ESPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia.

    Procedure: Ultrasound-guided Erector Spinae Plane Block

Interventions

  • ProcedureSerratus 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.

    Also known as: SPSIPB

  • ProcedureUltrasound-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.

    Also known as: ESPB

05

What researchers measure

Primary outcomes

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

    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.

    Time frame: Time Frame: T0: 3 months postoperatively

Secondary outcomes

  1. Neuropathic Pain Assessed by the DN4 Questionnaire

    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.

    Time frame: T0: 3 months postoperatively

06

Study locations

1 of 1 sites recruiting
  • University of Health Sciences Kocaeli City Hospital
    İzmit, Kocaeli 41200, Turkey (Türkiye)
    Recruiting
07

Registry details

Key details

Study ID
NCT07674836
Lead sponsor
Engin Çetin
Responsible party
Engin Çetin (principal investigator, Kocaeli City Hospital) — Sponsor-investigator
First posted
Jun 30, 2026
Start date
Jul 1, 2026
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 30, 2026

Study contacts

Engin Çetin, M.D.
Contact
Doccetin52@gmail.com
05321206004 ext. 90
Engin Çetin, M.D
Contact
Doccetin52@gmail.com
05321206004 ext. 90
Engin Çetin, M.D
principal investigator · Kocaeli City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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