An interventional study of PECS I Block and Local Anesthetic Infiltration in Breast Augmentation, Pain Management in Postoperative Care and Pain Management After Surgery, sponsored by Yeditepe University Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Yeditepe University Hospital · Not applicable, Interventional, and Treatment
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.
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.
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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
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
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 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.
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.
Time frame: Up to 6 hours post-surgery.
Opioid Consumption
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.
Time frame: Up to 24 hours post-surgery.
Opioid-Related Side Effects
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
Time frame: Up to 24 hours post-surgery
Chronic Pain Assessment
Presence of chronic pain in the breast region assessed using the Numeric Rating Scale (NRS) at the 3rd-month follow-up
Time frame: At 3 months post-surgery
Postoperative Complications
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.
Time frame: Up to 3 months post-surgery
Plan to share: Yes — The following specific individual participant data (IPD) will be shared: De-identified Participant Data: Demographic data (age, BMI, ASA classification). Pain scores measured using the Numeric Rating Scale (NRS) at predefined intervals. Postoperative opioid consumption (tramadol and morphine requirements). Incidence of postoperative complications (e.g., sensory changes, wound dehiscence). Data Dictionary: A comprehensive guide explaining the variables and coding used in the dataset to ensure accurate interpretation by other researchers. Exclusions: Personally identifiable information (e.g., names, contact information) will not be shared to maintain participant confidentiality. The data will be shared after the study is completed, analyzed, and the results are published in a peer-reviewed journal. Access will be granted only to researchers who provide a justified request and agree to the terms of a formal data-sharing agreement
Supporting information: Study protocol, Sap, Icf, Csr
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Yeditepe University Hospital