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

NCT ID: NCT06143020

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2025-08-25

Brief Summary

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.

Detailed 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

Conditions

Mammary Cancer; Erector Spinae Plane Block; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Erector spinae plane block group

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。

Group Type: EXPERIMENTAL

Erector spinae plane block

Intervention Type: PROCEDURE

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.

Control group

Control groups do not receive additional analgesia.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Erector spinae plane block

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.

Intervention Type: PROCEDURE

Other Intervention Names

Ultrasound-guided erector spinae plane block

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

Director of the department of anaesthesiology, Shanghai cancer center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ESPB of BCIR 2.0

Identifier Type: -

Identifier Source: org_study_id