Pain, PostoperativeNCT07747623
One-level and Bi-level ESPB Application in Patients Undergoing Breast Surgery
A study testing One-level Erector Spinae Plane Block and Bi-level Erector Spinae Plane Block in people with Pain, Postoperative and Breast Surgery, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain, Postoperative, Breast Surgery, Erector Spinae Plane Block
- What is being tested?
- One-level Erector Spinae Plane Block and Bi-level Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18 and 30 kg/m²
- Patients undergoing elective breast surgery
Who cannot join
- Patient refusing the procedure
- History of chronic analgesic or opioid therapy
- History of local anesthetic allergy
- Infection in the intervention area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
Musa Zengin, Associate Professor, 00905307716235, musazengin@gmail.com
Şeyma Ünal, Medical Doctor, 00905369781541, seymaarbc@icloud.com
About this study
Official title: Comparison of the Efficiency of One-Level and Bi-Level ESPB ESPB for Postoperative Analgesia in Patients Undergoing Breast Surgery
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.
- Being tested
- One-level Erector Spinae Plane Block, Bi-level Erector Spinae Plane 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.
One-level Erector Spinae Plane BlockProcedure or surgery
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.
Bi-level Erector Spinae Plane BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| One-level Erector Spinae Plane Block | Active comparator | 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. Receives: Procedure: One-level Erector Spinae Plane Block |
| Bi-level Erector Spinae Plane Block | Active comparator | 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. Receives: Procedure: Bi-level Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4th-hour after surgery
Secondary outcomes (4)
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.
Measured: Up to 24 hours after surgery
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.
Measured: Up to 24 hours after surgery
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.
Measured: Up to 24 hours after surgery
Side effects
Side effects, such as allergy to local anesthetics, hypotension, nausea/vomiting, and itching, will be recorded.
Measured: Up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start11 Sep 2026
- Primary completion10 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747623
- Sponsor's protocol ID
- AEŞH-EK-2026-111
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of One-Level and Bi-Level ESPB ESPB for Postoperative Analgesia in Patients Undergoing Breast Surgery
- ClinicalTrials.gov ID
- NCT07747623
- Acronym / sponsor ID
- AEŞH-EK-2026-111
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-level Erector Spinae Plane Block | Active comparator | Procedure: One-level Erector Spinae Plane BlockAfter 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. |
| Bi-level Erector Spinae Plane Block | Active comparator | Procedure: Bi-level Erector Spinae Plane BlockAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18 and 30 kg/m²
- Patients undergoing elective breast surgery
Key exclusion criteria (4 listed)
- Patient refusing the procedure
- History of chronic analgesic or opioid therapy
- History of local anesthetic allergy
- Infection in the intervention area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-level Erector Spinae Plane BlockOne-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. | Procedure or surgery | One-level Erector Spinae Plane Block |
| Bi-level Erector Spinae Plane BlockBi-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. | Procedure or surgery | Bi-level Erector Spinae Plane Block |
Primary outcome
Pain scores
Time frame: 4th-hour after surgery
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).
4 secondary outcomes
Pain scores
Time frame: Up to 24 hours after surgery
Pain scores
Time frame: Up to 24 hours after surgery
Tramadol Consumption
Time frame: Up to 24 hours after surgery
Side effects
Time frame: Up to 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-level Erector Spinae Plane Block and Bi-level Erector Spinae Plane Block in people with Pain, Postoperative and Breast Surgery, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Musa Zengin, Associate Professor (05307716235, musazengin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: 4th-hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.