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

NCT ID: NCT06758765

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-11-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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ESP group

The group that received erector spinae plane block

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type 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.

PECS group

The group that received PECSI-II blocks

Group Type EXPERIMENTAL

Pectoral Nerve Block

Intervention Type 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.

Interventions

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Erector Spinae Plane Block

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.

Intervention Type PROCEDURE

Pectoral Nerve Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Saglik Bilimleri University

OTHER

Sponsor Role lead

Responsible Party

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Taner Abdullah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Funda Gümüş Özcan, Prof

Role: STUDY_CHAIR

Basaksehir Cam ve Sakura State Hospital

Locations

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Basaksehir Cam ve Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 35991781 (View on PubMed)

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.

Reference Type RESULT
PMID: 33786681 (View on PubMed)

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.

Reference Type RESULT
PMID: 30396100 (View on PubMed)

Other Identifiers

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2022.02.44

Identifier Type: -

Identifier Source: org_study_id

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