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

NCT06143020 | Completed

• 1 other identifier: ESPB of BCIR 2.0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammary Cancer; Erector Spinae Plane Block; Postoperative Pain

Keywords

Mammary Cancer; implant reconstruction; erector spinae plane block; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Post-operative acute pain score at 6 hours

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

  6 hours After surgery

Secondary Outcomes (4)

• Postoperative quality of recovery score

  24 to 72 hours after the surgery

• Post-operative acute pain score

  1h, 12h,24, 48h, 72h after the surgery, separately.

• Cumulative opioid consumption after surgery

  48 hours after the surgery

• AUC of postoperative pain score

  72 hours after the surgery

Other Outcomes (3)

• Number of patients with nausea and vomiting

  24 to 72 hours after the surgery

• Intraoperative hemodynamic data

  During the whole surgery process.

• The number of patients receiving rescue analgesia.

  24 to 72 hours after the surgery

Study Arms (2)

Erector spinae plane block group

EXPERIMENTAL

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。

Procedure: Erector spinae plane block

Control group

NO INTERVENTION

Control groups do not receive additional analgesia.

Interventions

Erector spinae plane block 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.

Also known as: Ultrasound-guided erector spinae plane block

Erector spinae plane block group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jun Zhang, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of anaesthesiology, Shanghai cancer center

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: November 22, 2023
• Study Start: November 20, 2023
• Primary Completion: August 20, 2025
• Study Completion: August 25, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)