Evaluating Preoperative PECS I Block and Intraoperative Local Anesthetic Infiltration for Postoperative Pain in Breast Augmentation: A Prospective, Double-Blind, Split-Body Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Postoperative Pain Intensity
时间窗: 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.
次要结局
- Opioid Consumption(Up to 24 hours post-surgery.)
- Opioid-Related Side Effects(Up to 24 hours post-surgery)
- Chronic Pain Assessment(At 3 months post-surgery)
- Postoperative Complications(Up to 3 months post-surgery)
研究者
Mert Ersan
Asst. Prof.
Yeditepe University Hospital