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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Mammary Cancer, Erector Spinae Plane Block, Postoperative Pain

Intervention / Treatment
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* Procedure: Erector spinae plane block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector spinae plane block group<br>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<br>* 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.<br>* Other names: Ultrasound-guided erector spinae plane block;|
| No Intervention: Control group<br>Control groups do not receive additional analgesia. | |

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| AUC of postoperative pain score | Area under the curve(AUC) of pain score 72 hours after surgery | 72 hours after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammary Cancer, implant reconstruction, erector spinae plane block, Postoperative Pain