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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06719726
• Lead Sponsor: Yeditepe University Hospital

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.

Study Timeline

• Study Start: 2024-10-03
• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-01-03
• Study Completion: 2025-02-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Intensity	Up to 6 hours post-surgery.	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.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption	Up to 24 hours post-surgery.	Total tramadol consumption recorded within the first 6 hours and the first 24 hours postoperatively. This includes the amount administered via patient-controlled analgesia (PCA) and any additional doses required.
Opioid-Related Side Effects	Up to 24 hours post-surgery	Incidence of opioid-related side effects such as nausea, vomiting, constipation, and respiratory depression. These will be monitored and recorded for each participant during the postoperative hospital stay
Chronic Pain Assessment	At 3 months post-surgery	Presence of chronic pain in the breast region assessed using the Numeric Rating Scale (NRS) at the 3rd-month follow-up
Postoperative Complications	Up to 3 months post-surgery	Incidence of complications such as wound dehiscence, hematoma, infection, implant rupture, or sensory changes in the nipple. All complications will be recorded during routine follow-ups.

Trial Locations

Locations (1)

Yeditepe University Kozyatagi Hospital; 🇹🇷 Istanbul, Atasehir, Turkey