NCT06833697

Brief Summary

Breast surgery is one of the most common surgical procedures worldwide. Pain after surgery is an important issue because it affects recovery and mobility. It can also increase the risk of breathing problems. Although opioids are effective for pain relief, they can cause side effects like nausea, vomiting, and breathing difficulties. These side effects can negatively impact patients and their recovery. Reducing opioid use is important for ensuring patient safety and improving the recovery process. To manage pain after breast surgery, two types of nerve blocks can be used: the erector spinae plane block (ESPB) and the serratus posterior superior intercostal plane block (SPSIP). Both methods are effective for providing pain relief after surgery. However, there are not enough studies comparing which method is better. Purpose of the Study: The main aim of this study is to evaluate the effect of ultrasound-guided ESPB and SPSIP blocks on opioid use after breast surgery. Additionally, we will compare opioid-related side effects (like nausea, vomiting, and breathing problems) and pain levels measured with the NRS (Numeric Rating Scale) between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 13, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

January 13, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

Breast surgeryPostoperative painErector spinae plane blockSerratus Posterior Superior Intercostal Plane BlockOpioid consumptionUltrasound-guided nerve block

Outcome Measures

Primary Outcomes (1)

  • tramadol consumption

    Total tramadol consumption (mg) in the first 24 hours after surgery.

    irst 24 hours after the operation

Secondary Outcomes (2)

  • NRS (Numerical Rating Scale) pain scores

    first 24 hours after the operation

  • opioid-related side effects (such as nausea, vomiting, respiratory depression)

    first 24 hours after the operation

Study Arms (3)

Control group

NO INTERVENTION

Patients will not receive any nerve block

ESPB group

EXPERIMENTAL

Patients will receive an erector spinae plane block.

Procedure: erector spinae plane blockDrug: 0.25% bupivacaine

SPSIP group

EXPERIMENTAL

Patients will receive a serratus posterior superior intercostal plane block

Procedure: serratus posterior superior intercostal plane blockDrug: 0.25% bupivacaine

Interventions

the ESP block will be administered after surgery but before the patient is awakened, under sterile conditions and ultrasound guidance. Patient Positioning: The patient will be placed in the lateral position with the surgical side up, and a sterile ultrasound probe cover will be used. Ultrasound Imaging: A high-frequency (11-12 MHz) linear probe will be placed transversely at the T5 thoracic vertebra. Anatomy Identification: The erector spinae muscle and transverse processes will be visualized. Needle Insertion: Using an in-plane technique, the needle will be advanced to the transverse process. Injection: After confirming the needle position with 1-2 mL saline, 30 mL of 0.25% bupivacaine will be injected between the erector spinae muscle and transverse process, with spread monitored via ultrasound.

ESPB group

In Group 3, SPSIP block will be administered after surgery but before the patient is awakened, under sterile conditions and ultrasound guidance. Patient Positioning: The patient will be placed laterally with the surgical side up, using a sterile ultrasound probe cover. Ultrasound Imaging: A high-frequency (11-12 MHz) linear probe will be positioned sagittally at the scapula's upper corner to visualize the rhomboid major, trapezius, serratus posterior superior muscles, and the third rib. Anatomy Identification: The third rib and serratus posterior superior muscle will be identified. Needle Insertion: Using an in-plane technique, the needle will be advanced between the serratus posterior superior muscle and the third rib. Injection: After confirming the needle position with 1-2 mL saline, 30 mL of 0.25% bupivacaine will be injected into the space, with spread monitored via ultrasound.

SPSIP group

0.25% bupivacaine

ESPB groupSPSIP group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-80 years
  • Classified as ASA (American Society of Anesthesiologists) physical status I-III
  • Scheduled for breast surgery with axillary lymph node dissection

You may not qualify if:

  • Patients with a history of allergies
  • allergic to local anesthetics
  • pregnant women
  • psychiatric or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Cortes-Flores AO, Jimenez-Tornero J, Morgan-Villela G, Delgado-Gomez M, Zuloaga-Fernandez Del Valle CJ, Garcia-Renteria J, Rendon-Felix J, Fuentes-Orozco C, Macias-Amezcua MD, Ambriz-Gonzalez G, Alvarez-Villasenor AS, Urias-Valdez D, Chavez-Tostado M, Contreras-Hernandez GI, Gonzalez-Ojeda A. Effects of preoperative dexamethasone on postoperative pain, nausea, vomiting and respiratory function in women undergoing conservative breast surgery for cancer: Results of a controlled clinical trial. Eur J Cancer Care (Engl). 2018 Jan;27(1). doi: 10.1111/ecc.12686. Epub 2017 May 4.

    PMID: 28474341BACKGROUND
  • Ciftci B, Ekinci M, Yildiz Y. Erector Spinae Plane Block for a Patient who Underwent Both Bilateral Mastectomy and Right Video-Assisted Thoracic Surgery. Turk J Anaesthesiol Reanim. 2020 Apr;48(2):170-171. doi: 10.5152/TJAR.2019.01205. Epub 2019 Nov 11. No abstract available.

    PMID: 32259153BACKGROUND
  • Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.

    PMID: 37272274BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2025

First Posted

February 19, 2025

Study Start

January 27, 2025

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

only IPD used in the results publication

Locations