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

Comparison of the Efficiency of One-Level and Bi-Level ESPB ESPB for Postoperative Analgesia in Patients Undergoing Breast Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07747623
Enrollment
70
Registered
2026-08-05
Start date
2026-09-11
Completion date
2027-01-20
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

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 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.

Sponsors

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patient refusing the procedure * History of chronic analgesic or opioid therapy * History of local anesthetic allergy * Infection in the intervention area

Design outcomes

Primary

MeasureTime frameDescription
Pain scores4th-hour after surgeryPain 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).

Secondary

MeasureTime frameDescription
Pain scoresUp to 24 hours after surgeryPain 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.
Tramadol ConsumptionUp to 24 hours after surgeryPostoperative 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.
Side effectsUp to 24 hours after surgerySide effects, such as allergy to local anesthetics, hypotension, nausea/vomiting, and itching, will be recorded.

Countries

Turkey (Türkiye)

Contacts

CONTACTMusa Zengin, Associate Professor
musazengin@gmail.com05307716235

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026