NCT07541040

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
May 2026Aug 2026

First Submitted

Initial submission to the registry

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 15, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Post Operative PainOpioid Use

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Scores (NRS)

    Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0-10, where 0 indicates no pain and 10 indicates worst imaginable pain). Pain scores will be evaluated both at rest and during movement (coughing)

    T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively

Secondary Outcomes (1)

  • Total Opioid Consumption

    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

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: Serratus Posterior Superior Intercostal Plane Block

Interventions

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
ESPB BlockSPSIP Block

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Kocaeli City Hospital

İzmit, Kocaeli, 41200, Turkey (Türkiye)

Location

Related Publications (1)

  • 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: 41318393BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Engin Çetin, M.D

    Kocaeli City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Engin Çetin, M.D.

CONTACT

Engin Çetin, M.D

CONTACT

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
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).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 21, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations