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

Effect of Erector Spinae Plane Block 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Erector Spinae Plane Block; Mammary Cancer
• Intervention / Treatment: Procedure: Erector spinae plane block

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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。	Procedure: 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.; Other Names: Ultrasound-guided erector spinae plane block
No Intervention: Control group; Control groups do not receive additional analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of postoperative pain score	Area under the curve(AUC) of pain score 72 hours after surgery	72 hours after the 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).	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.	1h, 12h,24, 48h, 72h after the surgery, separately.
Cumulative opioid consumption after surgery	Cumulative opioid consumption after surgery	48 hours after the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients receiving rescue analgesia.	The number of patients receiving rescue analgesia.	24 to 72 hours after the surgery
Number of patients with nausea and vomiting	Number of patients who experienced nausea and vomiting after surgery.	24 to 72 hours after the surgery
Intraoperative hemodynamic data	Including mean blood pressure(mmHg), heart rate(beats/min) during the surgery.	During the whole surgery process.

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jun Zhang, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): March 5, 2024

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative Pain; Mammary Cancer; erector spinae plane block; implant reconstruction
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms
• Other Study ID Numbers: ESPB of BCIR 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No