Evaluation of the Onset and the Extent of Sensory Block After Thoracic ESP Block in Breast Surgery - a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The onset of sensory block after thoracic ESP block after one minute
研究概览
简要总结
The goal of this observational study is to to evaluate the changes in cold sensitivity and the onset of sensory block after performing a thoracic ESP block. It reflects the time it takes for the local anaesthetic to spread into the paravertebral space leading to changes in cold sensitivity in the chest.
The study population are patients undergoing simple quadrantectomy or partial resection with or without sentinel lymphnode removal, in the operating rooms of Santa Maria Goretti Hospital in Latina.
This study is observational because it simply describes and records the effects of a procedure (the ESP block) on treated patients during a period of observation.
Before surgery, unilateral thoracic ESP block (T4 level) with a sterile, ultrasound-guided technique will be performed. A timer will be started to mark the time for subsequent evaluations. At 1,3,5 and after every 5 minutes following the block up to 40 minutes or until induction of general anaesthesia, the cold sensitivity of the chest will be explored.
详细描述
Breast cancer is the most frequent cancer pathology in women, accounting for 30% of all cancer pathology in women in Italy. Treatment depends on the stage at diagnosis and the histotype, but the surgical approach remains the cornerstone of treatment with radical intent.
Ensuring adequate analgesia during breast surgery can be difficult due to the extensive nature of the surgery and the complex innervation of the breast.
The breast is a subcutaneous organ that receives innervation from the anterior and lateral cutaneous branches of the intercostal nerves T2 to T5 (with varying contributions from T1, T6 and T7) and the supraclavicular nerves from the cervical plexus (C3-C5). The anterior cutaneous branches of the intercostal nerves T2 to T5 cross the pectoralis major muscle near the sternum to innervate the medial quadrants of the breast. The supraclavicular nerves cross the clavicle and innervate the skin below the clavicle and part of the upper pole of the breast. The lateral skin branches of the intercostal nerves from T2 to T5 further divide into anterior and posterior divisions, which perforate the serratus muscle. The anterior divisions provide innervation to the lateral quadrants of the breast. The posterior divisions penetrate the subcutaneous tissue to innervate the lateral thoracic wall. The lateral cutaneous branch of T2 gives rise to the intercostobrachial nerve, which innervates the axilla and the medial upper arm. The first intercostal nerve rarely gives off a lateral cutaneous branch. The lateral and anterior branches of the different intercostal nerves frequently communicate with each other along their course, producing a highly variable pattern of innervation that does not adhere to the rigid dermatomeric segmentation.
Adequate pain control during and after breast surgery improves functional recovery and helps prevent the development of chronic post-operative pain.
Several neuroaxial and regional anaesthesia techniques have been proposed and studied for perioperative pain control.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •ASA score I-II-III.
- •Schedule of breast surgery
- •Schedule of ESPB
- •Consent to the study
排除标准
- •Allergy to local anaesthetics
- •Cardiopathies, nephropathies, hepatopathies, central or peripheral neuropathies uncompensated
- •Infection at the injection site
- •Uncooperative patient
- •BMI < 20, > 40
- •Difficulty in visualising target structures or the LA spread (failure of technique)
- •Pregnancy status
结局指标
主要结局
The onset of sensory block after thoracic ESP block after one minute
时间窗: One minute after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after three minutes
时间窗: 3 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after five minutes
时间窗: 5 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after 10 minutes
时间窗: 10 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after 15 minutes
时间窗: 15 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after 20 minutes
时间窗: 20 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after 25 minutes
时间窗: 25 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after 30 minutes
时间窗: 30 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after 35 minutes
时间窗: 35 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
The onset of sensory block after thoracic ESP block after 40 minutes
时间窗: 40 minutes after ESPB is performed
Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.
次要结局
未报告次要终点
研究者
Irene Lupelli
Doctor
Ospedale Santa Maria Goretti