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Completed

NCT Number: NCT06758765

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

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.

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Key information

Conditions

Breast Cancer Surgery Bites and Stings Breast Conserving Surgery Chemically-Induced Disorders Erector Spinae Plane Block Neurologic Manifestations Opioid Consumption Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Pectoral Nerve (PECS) Block Poisoning Postoperative Complications Postoperative Pain, Acute Signs and Symptoms Visual Analog Scale Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Basaksehir Cam ve Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane Block

Procedure

ESPB was applied to the patients in a sitting position. A high-frequency linear probe was used. Under sterile conditions, the USG probe was placed longitudinally approximately 2 cm lateral to the T4 spinous process. Skin, subcutaneous fat tissue, m. trapezius, rhomboid muscles, erector group muscles, transverse process, intercostal muscles, pleura and lung movements were visualized from superficial to deep structures. 1 ml of 2% lidocaine was injected into the estimated needle entry area. Then, with the block needle the m. trapezius, mm. rhomboidei and erector spinae muscles were passed in order with the in-plane method and the needle was brought into contact with the transverse process. Fascial separation was confirmed with 1-2 ml of saline solution and the block was performed by injecting 20 ml of 0.375% bupivacaine. The distribution of the drug was confirmed by observing it with USG.

pectoral nerve block

Procedure

The PECSI and PECSII blocks were applied concurrently.

In patients who will undergo PECS II, sterile conditions were prepared with the arm on the side to be operated on in the supine position and 90 degrees of abduction. The lateral and pectoral branches of the thoracoacromial artery were visualized between the PM and Pm muscles at the level of the 4th rib under USG guidance. The blocking needle was directed between the PM and Pm muscles for PECS I, 1-2 ml of saline was injected to verify fascial spread, and 10 ml of 0.375% bupivacaine was applied. Afterwards, fascial spread was confirmed by injecting 1-2 ml of saline between the pectoralis minor muscle and the serratur anterior muscle, and PECS II was performed by injecting 10 ml of 0.375% concentration bupivacaine. The distribution of the drug was confirmed by observing it with USG.

Primary outcomes

  1. Early postoperative Visual Analog Scale (VAS) scores

    Time frame: First hour after surgery

    The postoperative pain level that evaluated with evaluated with VAS at 0, 15, 30 and 60 minutes.

    Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain".

Secondary outcomes

  1. Additional opioid analgesic requirement in the postanesthesia care unit

    Time frame: First hour after surgery

    Patients who scored 4 and above in the pain score were administered 10 mg meperidine.

  2. Total opioid consumption after discharging from postanesthesia care unit

    Time frame: Between 1-24 hours after surgery

    The PCA device, which was applied to the patients at the 60th minute postoperatively, was left for patient use until the 24th hour postoperatively.

  3. Visual Analog Scale (VAS) during 24 hours follow-up after surgery

    Time frame: 1th, 4th, 6th, 12th, and 24th hours postoperatively

    VAS values after discharge from the postanesthesia care unit

    Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain".

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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