Trials / Completed
CompletedNCT06719726
PECS I Block vs. Local Infiltration in Breast Augmentation Pain Management
Evaluating Preoperative PECS I Block and Intraoperative Local Anesthetic Infiltration for Postoperative Pain in Breast Augmentation: A Prospective, Double-Blind, Split-Body Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Yeditepe University Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
| 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. |
Timeline
- Start date
- 2024-10-03
- Primary completion
- 2025-01-03
- Completion
- 2025-02-03
- First posted
- 2024-12-06
- Last updated
- 2025-07-16
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06719726. Inclusion in this directory is not an endorsement.