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

Fudan University

Status: Completed

Conditions: Postoperative Pain; Mammary Cancer; Erector Spinae Plane Block

Treatments: Procedure: Erector spinae plane block

Study type: Interventional

Funder types: Other

Identifiers

NCT06143020

ESPB of BCIR 2.0

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled for an radical mastectomy and implant reconstruction surgery
• Patients with American Society of Anesthesiologists (ASA) physical status I-II,
• aged 18-70 years

Exclusion criteria

• coagulation disorders,
• known allergy to study drugs,
• obesity (body mass index > 35 kg/m2),
• infection at the injection site,
• chronic opioid consumption, and an inability to use patient-controlled analgesia (PCA) device,
• patient refuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Erector spinae plane block group

Experimental group

Description:

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。

Treatment:

Procedure: Erector spinae plane block

Control group

No Intervention group

Description:

Control groups do not receive additional analgesia.