Erector Spinae Plane Block (ESPB) Versus Intravenous Lidocaine Infusion for Postoperative Pain and Quality of Recovery in Patients Undergoing Breast Reduction Surgery: A Single Center, Prospective, Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of recovery following breast reduction surgery
研究概览
简要总结
Elective breast reduction surgery is associated with moderate-to-severe postoperative pain and a risk of developing chronic postsurgical pain. Enhanced Recovery After Surgery (ERAS) protocols and the Procedure-Specific Postoperative Pain Management (PROSPECT) guidelines emphasize the importance of multimodal analgesia to reduce pain, minimize opioid consumption, and accelerate functional recovery following surgical procedures, including breast surgery.
The erector spinae plane block (ESPB) has demonstrated effectiveness in breast reduction surgery by reducing postoperative pain intensity, perioperative opioid and non-opioid analgesic consumption, and improving patient satisfaction and recovery time. Furthermore, the use of ESPB has been associated with a reduced incidence of postoperative nausea and vomiting. ESPB is performed with the patient in the sitting position and involves ultrasound-guided identification of the vertebral transverse processes on the side of the block, typically in the interscapular region, followed by the injection of approximately 20 mL of local anesthetic adjacent to the transverse process. When required, the procedure is performed bilaterally at the same vertebral level. ESPB is considered one of the simplest regional anesthesia techniques to perform.
Intravenous lidocaine infusion has been shown to significantly reduce opioid requirements and postoperative pain intensity across a wide range of surgical procedures, particularly in abdominal and breast surgery. Moreover, intraoperative lidocaine infusion has been associated with a reduced risk of chronic postsurgical pain following breast surgery.
This study was designed to investigate whether intraoperative intravenous lidocaine infusion is non-inferior to ESPB in reducing postoperative pain and improving the quality of recovery following non-oncological breast reduction surgery. Intravenous lidocaine infusion may provide analgesic efficacy and recovery outcomes comparable to those achieved with ESPB, thereby representing a less invasive alternative within a multimodal analgesic strategy.
详细描述
High-quality evidence supports the effectiveness of the erector spinae plane block (ESPB) in reducing postoperative pain following both non-oncological breast reduction surgery and oncological breast reconstructive procedures. In one of the prospective studies bilateral ESPB reduced strong opioid consumption during the first 24 postoperative hours by approximately 50%, from nearly 14 mg to 7 mg of morphine equivalents, while also significantly decreasing patient-reported pain intensity at all assessed time points during the first postoperative day. These findings demonstrate the analgesic efficacy of ESPB compared with standard care without regional anesthesia.
An accompanying editorial highlighted both the methodological quality of the study and the reliability of its findings, while noting that breast reduction surgery is not typically associated with severe postoperative pain. This observation is indirectly supported by the reported opioid requirements, as a total consumption of 14 mg of morphine during the first postoperative day is relatively low, whereas a reduction of approximately 6-7 mg, although statistically significant, may be of limited clinical relevance. The editorial further suggested that, despite its excellent safety profile, bilateral ESPB may be considered unnecessary by some clinicians when postoperative pain can be adequately controlled using pharmacological multimodal analgesia without the need for strong opioids.
Intraoperative intravenous lidocaine infusion is a well-established component of contemporary anesthetic practice and is widely used within multimodal analgesic protocols. A meta-analysis including twelve high-quality studies of oncological breast surgery demonstrated beneficial effects of intravenous lidocaine on both intraoperative and postoperative opioid consumption, as well as a reduction in the incidence of chronic postsurgical pain.
Based on the available evidence, this study was designed as prospective randomized non-inferiority trial to determine whether intraoperative intravenous lidocaine infusion provides postoperative pain control and quality-of-recovery outcomes comparable to those achieved with ESPB in patients undergoing non-oncological breast reduction surgery.
The study will include patients of the Department of Plastic, Reconstructive and Aesthetic Surgery, Centre of Postgraduate Medical Education, W. Orlowski Hospital, Warsaw, Poland, aged 18-75 years, American Society of Anesthesiology (ASA) physical status I-III, scheduled for elective breast reduction for non-oncological indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessment of the outcomes is performed by investigator blinded to type of intervention
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III
- •Scheduled for elective breast reduction surgery for non-oncological indications
排除标准
- •Refusal or inability to provide written informed consent
- •History of chronic somatic or neuropathic pain
- •Current psychiatric disorders or ongoing treatment with antidepressant medications
- •Poorly controlled cardiovascular disease
- •Known allergy or intolerance to amide local anesthetics, including lidocaine and bupivacaine
- •Current alcohol abuse or substance use disorder
结局指标
主要结局
Quality of recovery following breast reduction surgery
时间窗: 48 hours
Quality of Recovery score measured using the Quality of Recovery-15 questionnaire (QoR-15, 0 - 150, where 0 indicates very poor recovery and 150 indicates excellent recovery), assessed at least 24 hours after completion of surgery.
次要结局
- Postoperative opioid consumption(24 hours)
- Postoperative pain intensity 2 hours(2 hours)
- Postoperative pain intensity 4 hours(4 hours)
- Postoperative pain intensity 8 hours(8 hours)
- Postoperative pain intensity 24 hours(24 hours)
- Postoperative pain intensity 48 hours(48 hours)
- Occurence of chronic postoperative and neuropathic pain 1 month(1 month)
- Occurence of chronic postoperative and neuropathic pain 3 months(3 months)
- Occurence of chronic postoperative and neuropathic pain 6 months(6 months)
研究者
Bartosz Horosz, MD
MD,PhD
Centre of Postgraduate Medical Education