PECS I Block vs. Local Infiltration in Breast Augmentation Pain Management

NCT06719726 | Completed DMC

• 1 other identifier: 2024-KAEK-21/1031
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effectiveness of preoperative PECS I block and intraoperative local anesthetic infiltration in managing postoperative pain following breast augmentation surgery. The primary focus was to evaluate their impact on postoperative pain levels, perioperative remifentanil and postoperative opioid consumption and opioid-related side effects during the early recovery period.

Conditions

Breast Augmentation; Pain Management in Postoperative Care; Pain Management After Surgery; Pain Management

Keywords

breast augmentation; local infiltration; PECS 1 block; pectoral nerve block; postoperative pain management

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  The level of postoperative pain in each breast region (right vs. left) measured using the Numeric Rating Scale (NRS). Pain scores will be recorded at specific intervals: every 30 minutes for the first 2 hours, every 2 hours from 2 to 6 hours, at the 24th hour, on the 5th postoperative day, and at the 3rd month. The primary focus is the pain intensity within the first 6 hours postoperatively.

  Up to 6 hours post-surgery.

Secondary Outcomes (4)

• Opioid Consumption

  Up to 24 hours post-surgery.

• Opioid-Related Side Effects

  Up to 24 hours post-surgery

• Chronic Pain Assessment

  At 3 months post-surgery

• Postoperative Complications

  Up to 3 months post-surgery

Study Arms (2)

PECS I Block Intervention Arm

EXPERIMENTAL

This arm involves the application of a preoperative PECS I block with 10 mL of 0.5% bupivacaine under ultrasound guidance. The intervention targets the right breast, aiming to evaluate its effectiveness in managing postoperative pain compared to local anesthetic infiltration.

Procedure: PECS I Block

Local Anesthetic Infiltration Intervention Arm

EXPERIMENTAL

This arm involves the administration of intraoperative local anesthetic infiltration using 10 mL of 0.5% bupivacaine under direct visualization. The intervention targets the left breast, aiming to compare its effectiveness in managing postoperative pain against the PECS I block.

Procedure: Local Anesthetic Infiltration

Interventions

PECS I Block PROCEDURE

The PECS I block is a regional anesthesia technique performed preoperatively under ultrasound guidance. It involves the injection of 10 mL of 0.5% bupivacaine between the pectoralis major and pectoralis minor muscles to block the medial and lateral pectoral nerves. This procedure targets the right breast in the study to reduce postoperative pain and is compared to local anesthetic infiltration.

PECS I Block Intervention Arm

Local Anesthetic Infiltration PROCEDURE

Local anesthetic infiltration involves the intraoperative administration of 10 mL of 0.5% bupivacaine under direct visualization into the pectoralis major muscle prior to muscle transection. This procedure targets the left breast in the study for pain management and is compared to the PECS I block.

Local Anesthetic Infiltration Intervention Arm

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: Participation in this study is limited to self-identified women who are biologically female (cisgender women). Individuals whose self-identified gender does not align with their biological sex (e.g., transgender men, transgender women, or nonbinary individuals) are not eligible for this study. This criterion ensures consistency in evaluating outcomes related to breast augmentation surgery in a biologically female population.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18 to 59 years.
• ASA (American Society of Anesthesiologists) physical status I or II.
• Scheduled for primary breast augmentation surgery using a dual-plane or submuscular approach.
• Planned to receive silicone implants of identical volume and shape for both breasts.
• Able to provide written informed consent.
• Willing and able to comply with study procedures and follow-up assessments.

You may not qualify if:

• Planned subglandular or subfascial breast augmentation.
• Undergoing revision breast surgery.
• History of breast disease, previous breast or axillary surgery, or breast cancer.
• Preoperative breast pain or chronic pain syndromes (e.g., fibromyalgia, chronic headaches, back pain, complex regional pain syndrome, neuropathic pain, osteoarthritis, or radicular pain).
• BIRADS score \> 3 based on imaging (ultrasound/mammography) within the past year.
• Allergy to medications used in the study (e.g., bupivacaine, propofol, fentanyl, sevoflurane, cefazolin, paracetamol, ondansetron, tramadol, or morphine HCl).
• Coagulopathy or bleeding disorders.
• Pregnant or at risk of pregnancy.
• Inability to provide informed consent or communication difficulties.
• Significant medical conditions that may interfere with the study outcomes.

Sponsors & Collaborators

• Yeditepe University Hospital: lead

Study Sites (1)

Yeditepe University Kozyatagi Hospital

Istanbul, Atasehir, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mert Ersan, Asst.Prof.

  Yeditepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: This study utilized a Crossover design with a split-body approach, where each participant served as their own control. The intervention involved two pain management techniques: PECS I block: Administered to the right breast by an anesthesiologist before surgery. Local anesthetic infiltration: Performed on the left breast by the plastic surgeon during surgery. This design allowed for direct comparison of the efficacy of the two interventions (PECS I block vs. local anesthetic infiltration) in managing postoperative pain within the same participant. The crossover and split-body methodology minimized inter-individual variability and provided robust data on the relative effectiveness of each technique, as all other surgical and anesthetic factors were standardized across both sides.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: October 3, 2024
• Primary Completion: January 3, 2025
• Study Completion: February 3, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data and supporting information will be made available after the study is completed, analyzed, and the results are published in a peer-reviewed journal. IPD and supporting documents will be shared through a secure online repository or data-sharing platform, accessible only to approved researchers
• Access Criteria: Researchers must submit a formal data-sharing request, including a detailed explanation of how the data will be used. A data-sharing agreement must be signed to ensure the ethical use of the shared information, adherence to confidentiality, and compliance with relevant regulations.

Locations

TU (1)