Erector Spinae Plane Block: Anatomical Landmark Versus Ultra-sounded Guided Technique, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery
研究概览
简要总结
The erector spinae plane (ESP) block is a technique that helps alleviate acute pain. It involves injecting local anesthetic between the erector spinae muscle (ESM) and the vertebra's transverse process (TP). This technique can be guided by ultrasound or anatomical landmarks, and it can be performed while the patient is lying down, sitting or on their side.
详细描述
Ultrasound guidance has established itself as the norm for regional anesthesia procedures, enabling live visualization of anatomical structures and enhancing the precision and safety of needle insertion. Conversely, the blind technique relies on anatomical landmarks and the ability to palpate to direct needle insertion. Although the blind technique might provide simplicity and efficiency, uncertainties persist concerning its precision and possible associated risks. As the popularity of the ESPB increases, a relevant query emerges: Should it be conducted with ultrasound guidance or through a non-guided technique? This study was designed to validate the efficacy and safety of a landmark-guided ESPB technique compared to an ultrasound-guided ESPB technique for analgesia in breast surgery. The hypothesis was that the ultrasound and anatomical landmark techniques for ESPB would provide equivalent analgesia. The study's primary objective was to compare the success rate of both techniques. The secondary objectives were to compare the dermatomal block spread, analgesic effectiveness, and technique-related complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older.
- •Patients had an American Society of Anesthesiology (ASA) physical score of I-II.
- •Patients undergoing unilateral elective breast surgery.
排除标准
- •Patients had a contraindication to an ESPB (including coagulopathy, recent anticoagulant medication usage, or infection at the needle puncture site).
- •Patients had a history of opioid addiction, preoperative opioid use, and allergies to study medications.
- •Obesity (body mass index exceeding 35 kg/m²).
- •If the placement of ESPB was not completed due to technique difficulties.
- •Patients who expressed a lack of willingness to participate in the study were not considered eligible for participation.
研究组 & 干预措施
landmark guided ESPB technique
The ESPB was performed using the landmarks described by Vadera et al. (5). Before initiating the block procedure, the spinous process of the T4 vertebra and a point situated 3 cm to its side are marked at the appropriate level. The needle was inserted perpendicularly to the skin and advanced in all planes until it contacts the vertebra's transverse process. The depth at which the thoracic vertebra's transverse process lies from the skin can vary, ranging from 2 to 4 cm, contingent upon the individual's physique. The needle tip was positioned between the erector spinae muscle and the transverse process. The volume of local anesthetics was injected in this plane.
干预措施: Anatomical landmark-guided ESPB (Procedure)
ultrasound-guided ESPB technique
The block was performed based on the original description by Forero et al. (2). A high-frequency linear transducer (MyLab 70 Xvision, Esaote SpA, Florence, Italy) was positioned in the parasagittal plane 2 cm lateral to the T4 vertebra. Once the transverse process and the overlying erector spinae muscle were visible on the ultrasound, the needle was introduced using the in-plane technique. The needle was inserted in the cranial-to-caudal direction until it reached the tip of the transverse process. Following a negative aspiration and a successful hydro dissection, the local anesthetic solution was injected beneath the erector spinae muscle's fascia.
干预措施: Ultrasound-guided ESPB (Procedure)
结局指标
主要结局
To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery
时间窗: 30 minutes after regional block procedure
The primary outcome was the binary outcome: therapeutic success or failure of ESPB techniques in achieving cutaneous sensory block for breast surgery (from T1 to T6).
次要结局
- To compare the technique-related complications in both groups(During the regional block procedure.)
- To compare the analgesic effectiveness in both groups(intra- and 24 hours postoperatively)
- To compare the dermatomal block spread in both groups(30 minutes after regional block procedure.)
- To compare the analgesic effectiveness in both groups(The first 24 hours postoperatively at 1, 3, 6, 12, and 24 hours.)
- To compare the analgesic effectiveness in both groups(The first 24 hours postoperatively.)