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

Not Applicable

Completed

• Conditions: Postoperative Pain; Mammary Cancer; Erector Spinae Plane Block
• Interventions: Procedure: Erector spinae plane block

• Registration Number: NCT06143020
• Lead Sponsor: Fudan University

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

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2023-11-19
• Study Start: 2023-11-20
• Study First Posted: 2023-11-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-03-04
• Primary Completion: 2024-03-05
• Study Completion: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae plane block group	Erector spinae plane block	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。

Primary Outcome Measures

Name	Time	Method
Post-operative acute pain score at 6 hours	6 hours After surgery	11-point numerical rating scale(0=no pain, 10=worst pain) at 6th hour following the surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative quality of recovery score	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).
AUC of postoperative pain score	72 hours after the surgery	Area under the curve(AUC) of pain score 72 hours after surgery
Post-operative acute pain score	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.
Cumulative opioid consumption after surgery	48 hours after the surgery	Cumulative opioid consumption after surgery

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China