Trials / Completed

CompletedNCT06758765

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

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 72 (actual)

Sponsor: Istanbul Saglik Bilimleri University · Academic / Other
Sex: Female
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

Start date: 2022-03-01
Primary completion: 2022-08-31
Completion: 2022-11-30
First posted: 2025-01-06
Last updated: 2025-01-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06758765. Inclusion in this directory is not an endorsement.