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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorAtatürk Chest Diseases and Chest Surgery Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient refusing the procedure

History of chronic analgesic or opioid therapy

History of local anesthetic allergy

Infection in the intervention area

Trial design

Design model

Parallel

Treatments tested in this trial

  • One-level Erector Spinae Plane Block

    Procedure/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 Block

    Procedure/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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: One-level Erector Spinae Plane BlockActive comparator 1 intervention
Group B: Bi-level Erector Spinae Plane BlockActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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