Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative morphine consumption
研究概览
简要总结
Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. So, the investigators believed that the ESP block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery
排除标准
- •Coagulopathy
- •Allergy to amide-type local anesthetics
- •Infection at the ESP block injection site
- •Severe obesity (BMI > 35 kg/m2)
- •Liver or renal deficiency
- •Patients with anatomical deformities
- •Recent use of analgesic drugs
- •Patient refusal or inability to consent
研究组 & 干预措施
ESP block group
The bilateral erector spine plane (ESP) block will be performed with ultrasound guided, preoperatively. Following antiseptic preparation of block site with povidone iodine, ultrasound probe will be placed 3 cm lateral to spine at T5 level. After identifying the erector spinae muscle and transverse process, the overlying skin will be infiltrated with local anesthetics and 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL 1% lidocaine) will be injected deep to the erector spinae muscle. The same procedure will be performed on the other side. Also, patients will receive intravenous patient controlled analgesia with morphine, and 1 g acetaminophen for supplemental analgesia if pain score raises over 5/10 on NRS and 50 mg meperidine for rescue analgesic for persistent pain.
Interventions:
Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization
干预措施: Erector spinae plane block (Procedure)
sham block
A sham block will be performed while looking for intended location for ESP block placement. Skin will be infiltrated with local anesthetics but ESP block will not be performed, instead of ESP block 2 mL subcutaneous saline injection will be applied.
Intervention: Sham block Other: Standard Pain Followup and Monitorization
干预措施: sham block (Other)
结局指标
主要结局
Postoperative morphine consumption
时间窗: 24 hours
Morphine consumption in Patient Controlled Analgesia device
次要结局
- Pain assessed by NRS(24 hours)
- Degree of sedation(24 hours)
- Bilateral shoulder mobility(Preoperative and postoperative 4th, 8th, 12th, and 24th hours)
- Intraoperative anesthetic consumption(During operation time)
- Extubation and recovery time(Through surgical operation completion)
- Supplemental and rescue analgesic requirement(24 hours)
- Rate of opioid related side effects(24 hours)
- Patient satisfaction assessment(At the postoperative 24th hour)
- Rate of block related complications(Until discharge from hospital, up to 7 days postoperatively)
- Length of stay in hospital(Until discharge from hospital, up to 7 days postoperatively)
研究者
Demet Laflı Tunay
Principal Investigator
Cukurova University