Clinical trial NCT06758765: Erector Spinae Plane Block vs. PECS I-II Blocks After Breast-conserving Surgery
Official title: Comparison of the Effects of the Erector Spinae Plane Block and PECS I-II Blocks on Postoperative Opioid Consumption and Pain Scores of Patients After Breast-conserving Surgery: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Surgery
Breast Conserving Surgery
Erector Spinae Plane Block
Pectoral Nerve (PECS) Block
Visual Analog Scale
Opioid Consumption
Postoperative Pain, Acute
Keywords: erector spinae plane block
pectoral nerve (PECS) block
postoperative pain
breast conserving surgery
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the analgesic effects of ESPB and PECS II blocks in patients undergoing BCS. The main question it aims to answer is:

* Whether these two different block procedures will create a difference in postoperative pain scores.
* Comparison of total opioid consumption during the 24-hour postoperative period.

Our study included patients who were female, who were going to undergo elective breast-conserving surgery between March 2022 and August 2022.

Detailed description: The patients to be included in our study were divided into two groups as ESPB group or PECS II group by an anesthesia assistant independent of the study using a computer-based randomization program one day before the operation. All patients were informed about the block in the preoperative period, the use of the patient-controlled analgesia device to be used after the operation, and Visual Analog Scale (VAS) assessment. (Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain.)

On the day of the operation, group envelopes were placed in the patient files to indicate the groups in sealed envelopes. The appropriate anesthesia method was applied to the patient according to the group written on the patient's envelope by the relevant anesthesiologist on duty in the study. Our study was conducted as a randomized controlled and prospective study.

VAS scores at 0, 15, 30, 60 minutes postoperatively recorded for the primer output of the study. For the secondary outputs the total amount of analgesic used was recorded from the records of the PCA device. All patients' demographic data, intraoperative hemodynamic data, anesthesia duration, surgical duration and hospital stay, VAS at 4, 6, 12, 24 hours in the service follow-up, rescue analgesic requirements and numbers, nausea-vomiting and developing complications were evaluated and recorded. The evaluations were made by the anesthesiologist who was blind to the groups.

Eligibility criteria: Inclusion Criteria:

* female
* age between 18-70
* underwent breast conserving surgery

Exclusion Criteria:

* patients with coagulopathy
* known local anesthetic allergy
* abnormal liver function tests
* infection at the planned injection site
* chronic usage of analgesics
* under the age of 18
* over the age of 70
* ASA (American Society of Anesthesiologists) IV and higher risk classes
* limited cooperation for Visual Analog Scale (VAS) follow-ups

Primary outcomes:
measure: Early postoperative Visual Analog Scale (VAS) scores
timeFrame: First hour after surgery
Secondary outcomes:
measure: Additional opioid analgesic requirement in the postanesthesia care unit
timeFrame: First hour after surgery
measure: Total opioid consumption after discharging from postanesthesia care unit
timeFrame: Between 1-24 hours after surgery
measure: Visual Analog Scale (VAS) during 24 hours follow-up after surgery
timeFrame: 1th, 4th, 6th, 12th, and 24th hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura City Hospital
Study officials:
affiliation: Basaksehir Cam ve Sakura State Hospital
name: Funda Gümüş Özcan, Prof
role: STUDY_CHAIR
References:
citation: Bakeer A, Abdallah NM. Erector Spinae Plane Block Versus PECS Block Type II for Breast Surgery: A Randomized Controlled Trial. Anesth Pain Med. 2022 Apr 25;12(2):e122917. doi: 10.5812/aapm-122917. eCollection 2022 Apr.
citation: Hong B, Bang S, Oh C, Park E, Park S. Comparison of PECS II and erector spinae plane block for postoperative analgesia following modified radical mastectomy: Bayesian network meta-analysis using a control group. J Anesth. 2021 Oct;35(5):723-733. doi: 10.1007/s00540-021-02923-x. Epub 2021 Mar 30.
citation: Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.