How using ultrasound technology to guide the administration of an erector spinae plane block affects individuals undergoing a specific type of surgery called modified radical surgery for breast cancer

The impact of ultrasound-guided erector spinae plane block on hemodynamic stability and postoperative pain in patients undergoing modified radical surgery for breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16469348

Enrollment

Registered

2024-03-08

Start date

2023-01-05

Completion date

Unknown

Last updated

2024-03-18

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

Conditions

The impact of ultrasound-guided erector spinae plane block on hemodynamic stability and postoperative pain in patients undergoing modified radical surgery for breast cancer Surgery

Interventions

Study Design In our prospective, comparative study, 48 female patients aged 50-65 years undergoing modified radical surgery for breast cancer due to a breast tumor were included. Limiting the sample t

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female patients with confirmed breast cancer 2. Aged 50 to 65 years 3. Indication for radical surgery for breast cancer 4. American Society of Anesthesiologists (ASA) score of 1 to 2

Exclusion criteria

Exclusion criteria: 1. Refusal of the patient to participate in the study 2. Unsuccessful administration of the erector spinae plane block (ESPB) 3. Known allergy to the used drugs 4. Local infection at the injection site 5. Unable to cooperate 6. Deemed to have mental deficits and morbid obesity (BMI > 40 kg/m²)

Design outcomes

Primary

Measure	Time frame
1. Hemodynamic parameters (heart rate, systolic, diastolic, and mean arterial pressure) were continuously monitored using the Mindray iPM 12 monitor and recorded in 10 time intervals: T0 - baseline values, T1 - before induction of anesthesia, T2 – after induction of anesthesia, T3 – before surgical incision, T4 – 5 minutes after incision, T5 - 15 minutes af-ter incision, T6 - 25 minutes after incision, T7 - 35 minutes after incision, T8 – before the conclusion of the operation, T9 – after awakening from anesthesia. The percentage devia-tion from baseline values was calculated for each patient, and the frequency of variations exceeding 20% from baseline values was registered. Cardiovascular system stability was assessed as follows: Grade I - 0-10% deviation from baseline values; Grade II - 11-20%; Grade III - 21-30%; Grade IV - more than 30% deviation from baseline values. 2. To assess the degree of pain in the postoperative period, a visual analog scale (VAS) for pain was used, and the VAS score was recorded. VAS scores were measured at 5 time intervals: first in the post-anesthesia care unit 30 minutes after waking up and completing the surgery, then at 2, 6, 12, and 24 hours after waking up and completing the surgery.	—

Measure

Time frame

1. Hemodynamic parameters (heart rate, systolic, diastolic, and mean arterial pressure) were continuously monitored using the Mindray iPM 12 monitor and recorded in 10 time intervals: T0 - baseline values, T1 - before induction of anesthesia, T2 – after induction of anesthesia, T3 – before surgical incision, T4 – 5 minutes after incision, T5 - 15 minutes af-ter incision, T6 - 25 minutes after incision, T7 - 35 minutes after incision, T8 – before the conclusion of the operation, T9 – after awakening from anesthesia. The percentage devia-tion from baseline values was calculated for each patient, and the frequency of variations exceeding 20% from baseline values was registered. Cardiovascular system stability was assessed as follows: Grade I - 0-10% deviation from baseline values; Grade II - 11-20%; Grade III - 21-30%; Grade IV - more than 30% deviation from baseline values. 2. To assess the degree of pain in the postoperative period, a visual analog scale (VAS) for pain was used, and the VAS score was recorded. VAS scores were measured at 5 time intervals: first in the post-anesthesia care unit 30 minutes after waking up and completing the surgery, then at 2, 6, 12, and 24 hours after waking up and completing the surgery.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Serbia

Contacts

Public ContactAleksandar Nikolic

aleksandar.nikolic@medfak.ni.ac.rs+381 652778847

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026