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RecruitingNCT07747623Updated Sep 15, 2026

One-level and Bi-level ESPB Application in Patients Undergoing Breast Surgery

An interventional study of One-level Erector Spinae Plane Block and Bi-level Erector Spinae Plane Block in Pain, Postoperative, Breast Surgery and Erector Spinae Plane Block, sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Pain, Postoperative by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital — 6 open to participants now, 6 under way, none of them phase 3. Pain, Postoperative · Atatürk Chest Diseases and Chest Surgery Training and Research Hospital.

Planned enrollment
4th of 12
70 · median 60
Started
2026
with 2 others
No phase
12 of 16
4 open now
Registered
15th of 16
by date

Among the 16 studies in Pain, Postoperative by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, this one is the 4th largest by planned enrollment of the 12 interventional ones, is one of 3 that started in 2026, is one of 12 with no phase, and was the 15th registered.

By phase

16 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 4 open
Observational4 · 2 open

By the year they started

First in 2021; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 60 across the 12 interventional studies, 100 across the 4 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.

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02

Study summary

Acute pain after breast surgery can significantly reduce the quality of life for patients. If acute pain is not adequately treated, it can develop into chronic pain. Thoracic epidural analgesia, thoracic paravertebral block, erector spinae plane block, and serratus anterior plane block are frequently applied blocks. However, ESPB, being a fascial plane block, can yield inconsistent results regarding distribution and dermatomal area. In recent years, there has been an increase in publications applying ESPB from two levels to achieve wider distribution. As a result, this study aims to compare the analgesic efficacy of single-level (Thoracic 3) and two-level (Thoracic 2, Thoracic 4) ESPB applications.

03

Conditions studied

  • Pain, Postoperative
  • Breast Surgery
  • Erector Spinae Plane Block
  • Multimodal Analgesia

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04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 80 years
  • physical status I-II-III
  • between 18 and 30 kg/m²
  • Patients undergoing elective breast surgery

Exclusion criteria

Exclusion Criteria:

  • Patient refusing the procedure
  • History of chronic analgesic or opioid therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    One-level Erector Spinae Plane Block

    After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T3 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process.

    Procedure: One-level Erector Spinae Plane Block

  • Active comparator
    Bi-level Erector Spinae Plane Block

    After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T2 spinous process, 15 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T4 spinous process. Finally, 15 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.

    Procedure: Bi-level Erector Spinae Plane Block

Interventions

  • ProcedureOne-level Erector Spinae Plane Block

    One-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, and when the patient is placed in the lateral decubitus position. In applications, 30 ml of 0.25% bupivacaine will be injected at the T3 level.

  • ProcedureBi-level Erector Spinae Plane Block

    Bi-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, and when the patient is placed in the lateral decubitus position. In applications, 15 ml of 0.25% bupivacaine at T2 level and 15 ml of 0.25% bupivacaine at T4 level will be injected.

06

What researchers measure

Primary outcomes

  1. Pain scores

    Pain will be assessed at the 4th-hour rest using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain).

    Time frame: 4th-hour after surgery

Secondary outcomes

  1. Pain scores

    Pain will be assessed at rest using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 2nd, 12th, and 24th hours after surgery.

    Time frame: Up to 24 hours after surgery

  2. Pain scores

    Pain will be assessed while coughing using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 2nd, 6th, 12th, and 24th hours after surgery.

    Time frame: Up to 24 hours after surgery

  3. Tramadol Consumption

    Postoperative intravenous tramadol infusion therapy will be administered with the patient-controlled analgesia (PCA) method. Thanks to PCA, how much morphine the patient needs will be followed in mg.

    Time frame: Up to 24 hours after surgery

  4. Side effects

    Side effects, such as allergy to local anesthetics, hypotension, nausea/vomiting, and itching, will be recorded.

    Time frame: Up to 24 hours after surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Jan 2027, 3 months after the start.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 3 months is below that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2026
First posted
Aug 5, 2026
StartActual
Sep 11, 2026
Primary completionEst.
Jan 10, 2027
CompletionEst.
Jan 20, 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07747623
Lead sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Responsible party
Musa Zengin (Principal İnvestigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital) — Principal investigator
First posted
Aug 5, 2026
Start date
Sep 11, 2026
Primary completion
Jan 10, 2027 (estimated)
Completion
Jan 20, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Musa Zengin, Associate Professor
Contact
musazengin@gmail.com
05307716235

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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