Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Pharmaceutical Solutions

Anesthetics

Dexmedetomidine

Ropivacaine

Anesthetics, Local

Before surgery, an ultrasound-guided ESPB was performed. 30 mL of 0.375% ropivacaine and 0.5μ g/kg dexmedetomidine mixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle.

Ropivacaine is produced by AstraZeneca AB under the trade name of Naropin, and the specifications are 75 mg / 10 ml. Dexmedetomidine is produced by HengRui medical China and the specifications are 100μg / 1 ml。

Control groups do not receive additional analgesia.

In the ESPB group, the patients were placed in the lateral decubitus position. The ultrasound probe was located in longitudinal orientation at the level of the T4 spinous process and then placed 3 cm laterally from the midline to the side involved in the surgery. The ultrasound landmarks, T4 transverse process, and the overlying trapezius, rhomboideus, and erector spinae muscles, were identified. Under aseptic conditions, an 80-mm 21-gauge block needle was inserted in-plane at an angle of 30-40° in the cranial-to-caudal direction until the tip contacted the T4 transverse process.After the hydrodissection with 2-3 mL of isotonic saline solution confirmed the correct needle tip position, the intermixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle. Local anesthetic spread in a fascial longitudinal pattern deep to the erector spinae muscle was visualized using ultrasound guidance.

Erector spinae plane block

Jun Zhang, PhD

Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and more severe postoperative pain.ESPB is a new nerve block method which thought to reduce pain after thoracic and breast surgery.However, there are few studies on radical mastectomy combined breast reconstruction. So, this randomized controlled study is conducted to explore its impact on postoperative pain and thus provide more data guidance for clinical.

Patients: 100 breast cancer patients who are planned radical mastectomy combined breast reconstruction Intervention: General anesthesia + erector spinae plane block Control ： General anesthesia Outcome: NRS(Numerical rating scale) of postoperative pain at the sixth hour Study:RCT

Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction

Effect of Erector Spinae Plane Block on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction

Number of patients who experienced nausea and vomiting after surgery.

Including mean blood pressure(mmHg), heart rate(beats/min) during the surgery.

The number of patients receiving rescue analgesia.

11-point numerical rating scale(0=no pain, 10=worst pain) at 6th hour following the surgery

The QoR-15 will be used to evaluate postoperative quality of recovery from 15 dimensions. The QoR-15 scale is a global measurement of postoperative recovery, consisting of 15 items with 10 points each, with a total score ranging from 0 (QoR very poor) to 150 (QoR very good).

Pain scores at other time points except for the primary outcome. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.

Cumulative opioid consumption after surgery

Area under the curve(AUC) of pain score 72 hours after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction	NCT06143020	Mammary Cancer Erector Spinae ... Postoperative P...	Erector spinae ...	18 Years - 70 Years	Fudan University
Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction	NCT06143020	Mammary Cancer Erector Spinae ... Postoperative P...	Erector spinae ...	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for implant reconstruction