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

Yeditepe University Hospital

Status: Completed

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

Treatments: Procedure: PECS I Block; Procedure: Local Anesthetic Infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT06719726

2024-KAEK-21/1031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

PECS I Block Intervention Arm

Experimental group

Description:

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.

Treatment:

Procedure: PECS I Block

Local Anesthetic Infiltration Intervention Arm

Experimental group

Description:

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.

Treatment:

Procedure: Local Anesthetic Infiltration