A Comparative Study of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Opioid Consumption Following Breast and Axillary Dissection Surgery
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
January 27, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 11, 2025
September 1, 2025
6 months
January 13, 2025
September 10, 2025
Conditions
Keywords
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 INTERVENTIONPatients will not receive any nerve block
ESPB group
EXPERIMENTALPatients will receive an erector spinae plane block.
SPSIP group
EXPERIMENTALPatients will receive a serratus posterior superior intercostal plane block
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.
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.
Eligibility Criteria
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)
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: 28474341BACKGROUNDCiftci 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: 32259153BACKGROUNDCiftci 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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