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

NCT ID: NCT06719726

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2025-02-03

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.

Detailed Description

Breast augmentation is one of the most performed procedures in aesthetic surgery worldwide.These techniques, which involve muscle dissection and manipulation, tend to be more painful compared to subglandular and subfascial placements. Thus, managing postoperative pain effectively becomes a critical aspect of patient recovery and satisfaction.

To address postoperative pain in breast augmentation, various techniques, including regional anesthesia such as pectoral nerve blocks, local anesthetic infiltration, and pocket irrigation, are employed.

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.

This prospective, double-blind, split-body design study was conducted at Yeditepe University Faculty of Medicine, Plastic, Reconstructive, and Aesthetic Surgery Department, in collaboration with the Anesthesiology and Reanimation Department.

The anesthesia induction and PECS I blocks for the right breasts were performed by the same anesthesiologist in all patients (O.K.). Breast augmentation surgeries and local anesthetic infiltrations for the left breasts were performed by the same plastic surgeon (M.E.). Postoperative pain assessments were conducted by a different anesthesiologist who was blinded to the study design.

Postoperative pain was assessed using the Numeric Rating Scale (NRS), ranging from "0 = no pain" to "10 = unbearable pain." Pain assessments were performed every 30 minutes for the first 2 hours, every 2 hours between 2 and 6 hours, and at the 24ᵗʰ hour postoperatively.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PECS I Block Intervention Arm

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.

Group Type: EXPERIMENTAL

PECS I Block

Intervention Type: 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.

Local Anesthetic Infiltration Intervention Arm

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.

Group Type: EXPERIMENTAL

Local Anesthetic Infiltration

Intervention Type: 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.

Interventions

PECS I Block

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.

Intervention Type: PROCEDURE

Local Anesthetic Infiltration

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yeditepe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mert Ersan

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mert Ersan, Asst.Prof.

Role: PRINCIPAL_INVESTIGATOR

Yeditepe University

Locations

Yeditepe University Kozyatagi Hospital

Istanbul, Atasehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024-KAEK-21/1031

Identifier Type: -

Identifier Source: org_study_id