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Erector Spinae Plane Block vs. PECS I-II Blocks After Breast-conserving Surgery

I

Istanbul Saglik Bilimleri University

Status

Completed

Conditions

Breast Cancer Surgery
Postoperative Pain, Acute
Erector Spinae Plane Block
Breast Conserving Surgery
Opioid Consumption
Visual Analog Scale
Pectoral Nerve (PECS) Block

Treatments

Procedure: Erector Spinae Plane Block
Procedure: Pectoral Nerve Block

Study type

Interventional

Funder types

Other

Identifiers

NCT06758765
2022.02.44

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

72 participants in 2 patient groups

ESP group
Experimental group
Description:
The group that received erector spinae plane block
Treatment:
Procedure: Erector Spinae Plane Block
PECS group
Experimental group
Description:
The group that received PECSI-II blocks
Treatment:
Procedure: Pectoral Nerve Block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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