An interventional study of Erector spinae plane block in Mammary Cancer, Erector Spinae Plane Block and Postoperative Pain, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Fudan University · Not applicable, Interventional, and Treatment
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
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This study's enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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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 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.
Also known as: Ultrasound-guided erector spinae plane block
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
Time frame: 6 hours After surgery
Postoperative quality of recovery score
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).
Time frame: 24 to 72 hours after the surgery
Post-operative acute pain score
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.
Time frame: 1h, 12h,24, 48h, 72h after the surgery, separately.
Cumulative opioid consumption after surgery
Cumulative opioid consumption after surgery
Time frame: 48 hours after the surgery
AUC of postoperative pain score
Area under the curve(AUC) of pain score 72 hours after surgery
Time frame: 72 hours after the surgery
Number of patients with nausea and vomiting
Number of patients who experienced nausea and vomiting after surgery.
Time frame: 24 to 72 hours after the surgery
Intraoperative hemodynamic data
Including mean blood pressure(mmHg), heart rate(beats/min) during the surgery.
Time frame: During the whole surgery process.
The number of patients receiving rescue analgesia.
The number of patients receiving rescue analgesia.
Time frame: 24 to 72 hours after the surgery
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Fudan University