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Analgesic efficacy of the single-level vs bi-level erector spinae plane block in mastectomy: a prospective randomized controlled trial

Analgesic efficacy of the single-level vs bi-level erector spinae plane block in mastectomy: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250427001
Enrollment
68
Registered
2025-04-27
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Female patients aged 18-70 years undergoing elective mastectomy with or without axillary lymph node dissection Mastectomy, Breast Neoplasms, Elective Surgical Procedures

Interventions

An ESPB was performed at the level of the T4 transverse process, and 30 mL of 0.33 percent bupivacaine with adrenaline (1:200,000) was injected. Non-penetrating needle contact was then performed at th
Experimental Procedure/Surgery,Experimental Procedure/Surgery
Single-level ESPB,Bi-level ESPB

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.   Female patients aged between 18-70 years 2.   Patients with an American Society of Anesthesiologists (ASA) physical status I-III 1.   Patients scheduled for an elective unilateral mastectomy with or without axillary lymph node dissection (ALND) 2.   Patients who have provided written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1.      Patients with abnormal coagulation profiles 2.      Patients with known allergies to any of the study drugs 3.      Patients with a skin infection at the needle puncture sites 4.      Patients who are unable to understand or use the numeric pain rating scale or patient-controlled analgesia (PCA) pump 5.      Morbidly obese patients (BMI is greater than or equal to 40 kg/m2) 6.      Patients with body weight less than 50 kg 7.      Patients with severe liver dysfunction (Child-Pugh score > 9) Patients with a history of chronic opioid use

Design outcomes

Primary

MeasureTime frame
24-hour postoperative morphine consumption within 24 hours total morphine consumption within 24-hour postoperative

Secondary

MeasureTime frame
Pain scores within 24 hours Numeric rating scale (NRS) pain scores at rest, ranging from 0 (no pain) to 10 (worst imaginable pain), recorded in the PACU and at 6, 12 and 24 hours postoperatively.,Incidences of nausea and vomiting during the 24-hour postoperative period within 24 hours Patient reported outcome

Countries

Thailand

Contacts

Public ContactNolchanok Eamjitmetta

Department of Anesthesiology Faculty of Medicine Ramathibodi Hospital, Mahidol University

Nolchanok.eamj@gmail.com66879969322

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026