Clinical trial NCT06719726: PECS I Block vs. Local Infiltration in Breast Augmentation Pain Management
Official title: Evaluating Preoperative PECS I Block and Intraoperative Local Anesthetic Infiltration for Postoperative Pain in Breast Augmentation: A Prospective, Double-Blind, Split-Body Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative Pain Intensity
timeFrame: Up to 6 hours post-surgery.
Secondary outcomes:
measure: Opioid Consumption
timeFrame: Up to 24 hours post-surgery.
measure: Opioid-Related Side Effects
timeFrame: Up to 24 hours post-surgery
measure: Chronic Pain Assessment
timeFrame: At 3 months post-surgery
measure: Postoperative Complications
timeFrame: Up to 3 months post-surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University Kozyatagi Hospital
state: Atasehir
Study officials:
affiliation: Yeditepe University
name: Mert Ersan, Asst.Prof.
role: PRINCIPAL_INVESTIGATOR
References: