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

NCT07674836 | Not Yet Recruiting

• 1 other identifier: KSH-ANREA-EC-07
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Opioid Use

Keywords

Post Operative Pain; Opioid Use

Outcome Measures

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: T0: 3 months postoperatively

Secondary Outcomes (1)

• Neuropathic Pain Assessed by the DN4 Questionnaire

  T0: 3 months postoperatively

Study Arms (2)

SPSIP Block

ACTIVE COMPARATOR

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

ESPB Block

ACTIVE COMPARATOR

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

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.

Also known as: SPSIPB

SPSIP Block

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.

Also known as: ESPB

ESPB Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Engin Çetin: lead

Study Sites (1)

University of Health Sciences Kocaeli City Hospital

İzmit, Kocaeli, 41200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Engin Çetin, M.D

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engin Çetin, M.D.

CONTACT

05321206004; Doccetin52@gmail.com

Engin Çetin, M.D

CONTACT

05321206004; Doccetin52@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the outcome assessor will be blinded to group allocation. The anesthesiologist performing the block will not be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block (SPSIPB) or erector spinae plane block (ESPB)

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

TU (1)