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

NCT06758765 | Completed

• 1 other identifier: 2022.02.44
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Early postoperative Visual Analog Scale (VAS) scores

  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".

  First hour after surgery

Secondary Outcomes (3)

• Additional opioid analgesic requirement in the postanesthesia care unit

  First hour after surgery

• Total opioid consumption after discharging from postanesthesia care unit

  Between 1-24 hours after surgery

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

  1th, 4th, 6th, 12th, and 24th hours postoperatively

Study Arms (2)

ESP group

EXPERIMENTAL

The group that received erector spinae plane block

Procedure: Erector Spinae Plane Block

PECS group

EXPERIMENTAL

The group that received PECSI-II blocks

Procedure: Pectoral Nerve Block

Interventions

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.

ESP group

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.

PECS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Because breast cancer is very rare in men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35991781 RESULT

• 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.

  PMID: 33786681 RESULT

• 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.

  PMID: 30396100 RESULT

MeSH Terms

Conditions

Bites and Stings; Pain, Postoperative

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Funda Gümüş Özcan, Prof

  Basaksehir Cam ve Sakura State Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 6, 2025
• Study Start: March 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: November 30, 2022
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

TU (1)