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NCT Number: NCT06143020

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

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.

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Key information

Conditions

Mammary Cancer Breast Diseases Breast Neoplasms Erector Spinae Plane Block Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ultrasound-guided erector spinae plane block

Primary outcomes

  1. Post-operative acute pain score at 6 hours

    Time frame: 6 hours After surgery

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

Secondary outcomes

  1. Postoperative quality of recovery score

    Time frame: 24 to 72 hours after 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).

  2. Post-operative acute pain score

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

    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.

  3. Cumulative opioid consumption after surgery

    Time frame: 48 hours after the surgery

    Cumulative opioid consumption after surgery

  4. AUC of postoperative pain score

    Time frame: 72 hours after the surgery

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

Other outcomes

  1. Number of patients with nausea and vomiting

    Time frame: 24 to 72 hours after the surgery

    Number of patients who experienced nausea and vomiting after surgery.

  2. Intraoperative hemodynamic data

    Time frame: During the whole surgery process.

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

  3. The number of patients receiving rescue analgesia.

    Time frame: 24 to 72 hours after the surgery

    The number of patients receiving rescue analgesia.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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