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Breast SurgeryNCT06833697

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

A study testing erector spinae plane block, serratus posterior superior intercostal plane block and 0.25% bupivacaine in people with Breast Surgery and Erector Spinae Plane Block, run by Medipol University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
erector spinae plane block, serratus posterior superior intercostal plane block and 0.25% bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Jan 2025to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Medipol University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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: A Randomized Controlled Trial

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.

Read more

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.

Read the detailed description

Introduction Breast surgery is one of the most commonly performed surgical procedures worldwide. Postoperative pain is a significant issue as it impacts recovery and mobilization. Additionally, postoperative pain increases the risk of respiratory complications.

Although opioid analgesics are effective in controlling pain, their side effects, such as nausea, vomiting, and respiratory depression, can lead to undesirable outcomes. Reducing opioid use is critical for both patient safety and improving the quality of recovery.

For managing postoperative pain following breast surgery, the erector spinae plane block (ESPB) and the more recently introduced serratus posterior superior intercostal plane block (SPSIP) have been utilized. Both techniques have been effectively used for analgesia in patients undergoing breast surgery.

However, there is insufficient evidence in the literature comparing the efficacy of these two techniques in this context.

Aim of the Study The primary aim of this study is to evaluate the effect of ultrasound-guided ESPB and SPSIP blocks on postoperative opioid consumption following breast surgery. Additionally, the secondary aim is to compare opioid-related side effects (e.g., nausea, vomiting, respiratory depression) and postoperative NRS (Numerical Rating Scale) pain scores between the groups.

Materials and Methods This prospective, randomized controlled trial will be conducted at Medipol Mega University Hospital on patients undergoing breast surgery and axillary lymph node dissection. The study aims to evaluate the effects of ESPB and SPSIP applications on postoperative opioid consumption and pain management. Written and verbal informed consent will be obtained from all participants prior to the study.

Patient Selection Patients aged 18-80 years, classified as ASA (American Society of Anesthesiologists) physical status I-III, and scheduled for breast surgery with axillary lymph node dissection will be included. Patients with a history of allergies, known allergy to local anesthetics, pregnancy, or psychiatric or neurological disorders will be excluded.

Group Allocation

Patients will be randomized into three groups:

Group 1 (Control group): Patients will not receive any nerve block. Group 2 (ESPB group): Patients will receive an erector spinae plane block. Group 3 (SPSIP group): Patients will receive a serratus posterior superior intercostal plane block.

Anesthesia Management All patients will receive routine anesthesia protocols. After entering the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO₂), and non-invasive blood pressure. Premedication with 2 mg intravenous midazolam will be administered.

Anesthesia induction will include 2-2.5 mg/kg IV propofol, 1-1.5 µg/kg IV fentanyl, and 0.6 mg/kg IV rocuronium, followed by intubation. Patients will be ventilated with a 50% oxygen-air mixture. Maintenance of anesthesia will be achieved with intermittent doses of midazolam, fentanyl, and rocuronium. Ventilator settings will include a tidal volume of 6-8 mL/kg and an end-tidal CO₂ of 30-35 mmHg.

All patients will receive 1 g intravenous paracetamol and 100 mg intravenous tramadol 30 minutes before the end of surgery. To prevent postoperative nausea and vomiting, 4 mg intravenous ondansetron will be administered.

Erector Spinae Plane Block Procedure In Group 2, ESPB will be performed following the surgical procedure but before the patient is awakened. The block will be performed under sterile conditions using ultrasound guidance.

Patient Positioning and Preparation: The patient will be positioned laterally with the surgical side up. A sterile ultrasound probe cover will be used.

Ultrasound Imaging: A high-frequency (11-12 MHz) linear ultrasound probe will be placed transversely over the T5 thoracic vertebra.

Identification of Anatomy: The erector spinae muscle and transverse processes will be identified.

Needle Insertion: Using an in-plane technique, the block needle will be advanced to the transverse process.

Injection Confirmation: After confirming the needle position with a 1-2 mL saline injection, 30 mL of 0.25% bupivacaine will be injected between the erector spinae muscle and the transverse process. Spread of the local anesthetic will be monitored via ultrasound.

Serratus Posterior Superior Intercostal Plane Block Procedure In Group 3, SPSIPB will also be performed following the surgical procedure but before the patient is awakened. The block will be performed under sterile conditions using ultrasound guidance.

Patient Positioning and Preparation: The patient will be positioned laterally with the surgical side up. A sterile ultrasound probe cover will be used.

Ultrasound Imaging: A high-frequency (11-12 MHz) linear ultrasound probe will be placed sagittally at the upper corner of the scapula. The rhomboid major, trapezius, serratus posterior superior muscles, and the third rib will be visualized.

Identification of Anatomy: The third rib and serratus posterior superior muscle will be identified.

Needle Insertion: Using an in-plane technique, the block needle will be advanced between the serratus posterior superior muscle and the third rib.

Injection Confirmation: After confirming the needle position with a 1-2 mL saline injection, 30 mL of 0.25% bupivacaine will be injected into the space between the serratus posterior superior muscle and the third rib. Spread of the local anesthetic will be monitored via ultrasound.

Postoperative Assessment Pain levels will be assessed during the first 24 hours postoperatively. Patients will routinely receive 1,000 mg paracetamol three times daily. Pain scores will be evaluated using the Numerical Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable."

Pain scores at rest and during mobilization will be recorded at the recovery unit, as well as at 3, 6, 12, 18, and 24 hours postoperatively. If the NRS score is ≥4, 1 mg/kg IV tramadol will be administered as rescue analgesia. The total amount of rescue analgesic used, postoperative opioid consumption, and side effects such as nausea, vomiting, itching, and complications like hematoma will be documented.

Being tested
erector spinae plane block, serratus posterior superior intercostal plane block, 0.25% bupivacaine
Keywords
Breast surgery, Postoperative pain, Erector spinae plane block, Serratus Posterior Superior Intercostal Plane Block, Opioid consumption, Ultrasound-guided nerve block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erector spinae plane blockProcedure or surgery

    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.

  • serratus posterior superior intercostal plane blockProcedure or surgery

    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.

  • 0.25% bupivacaineDrug

    0.25% bupivacaine

Study groups in NCT06833697
Study groupRoleWhat they receive
Control groupNo interventionPatients will not receive any nerve block
ESPB groupExperimentalPatients will receive an erector spinae plane block.
Receives: Procedure: erector spinae plane block; Drug: 0.25% bupivacaine
SPSIP groupExperimentalPatients will receive a serratus posterior superior intercostal plane block
Receives: Procedure: serratus posterior superior intercostal plane block; Drug: 0.25% bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tramadol consumption

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

    Measured: irst 24 hours after the operation

Secondary outcomes (2)
  1. NRS (Numerical Rating Scale) pain scores

    NRS (0-10) scores will be measured at 3, 6, 12, 18, and 24 hours during both rest and mobilization in the postoperative period.

    Measured: first 24 hours after the operation

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

    The incidence of opioid-related side effects (e.g., nausea, vomiting, respiratory depression) will be recorded and compared between groups.

    Measured: first 24 hours after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start27 Jan 2025
  3. Primary completion1 Aug 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06833697
Sponsor's protocol ID
breast ESP vs SPSİP
Status last verified
Sep 2025
First submitted
13 Jan 2025
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: only IPD used in the results publication

Publications

  • 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.

    PubMed 28474341
  • 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.

    PubMed 32259153
  • 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.

    PubMed 37272274

Questions about this trial

What is this clinical trial studying?

A study testing erector spinae plane block, serratus posterior superior intercostal plane block and 0.25% bupivacaine in people with Breast Surgery and Erector Spinae Plane Block, run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tramadol consumption (time frame: irst 24 hours after the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06833697, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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