Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery

Study Overview
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Brief Summary
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This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node biopsy (SLNB). Each one-third of patients will have ESP block and pectoralis nerve block (PECS II) 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.

Detailed Description
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It has been proven that PECS II and ESP both supply effective analgesia in the first 24 hours after mastectomy. But they do so by different mechanishms. This study is to survey that ESP and PECS II may supply acute and chronic analgesia by reducing pain scores in the first 24 hours and 3 months after the surgery, also the comparison of the analgesic activity among themselves for acute / chronic pain and opioid consumption will be searched. In this study patients are divided into three groups. Patients in PECS group will have PECS II block in a separate section from the operating rooms (PNB practice room). In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively. Patients in ESP group will have ESP block in a separate section from the operating rooms (PNB practice room). In addition, PCA will be used in the first 24 hours postoperatively. Patients in control group will not be performed nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, PCA will be used in the first 24 hours postoperatively.

Official Title
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Research of the Effects of Pectoralis Nerve Block II and Erector Spina Plan Block in Breast Cancer Surgery

Conditions
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Anesthesia, Analgesia, Acute Pain, Chronic Pain, Pectoralis Nerve Block, Erector Spine Plane Block, Patient Controlled Analgesia

Intervention / Treatment
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* Procedure: Pectoralis nerve block II
* Procedure: Erector spine plane block
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy Exclusion Criteria: Age <18 or> 65, ASA 3-4 patients Obesity (> 100 kg, BMI> 35 kg / m2) Patients undergoing bilateral mastectomy Pregnancy Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site) Serious renal, cardiac, hepatic disease Hypersensitivity to local anesthetics or a history of allergy Patients with a history of opioid use longer than four weeks Patients with psychiatric disorders or communication difficulties Patients with chest deformity Patients with previous breast surgery except diagnostic biopsies Patients who do not want to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated generated random numbers.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PECS II or ESP<br>PECS II or ESP block are performed 30 minutes before general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively. | Procedure: Pectoralis nerve block II<br>* PECS II block will be performed 30 min. before general anesthesia.<br>* Other names: PECS II;Procedure: Erector spine plane block<br>* ESP block will be performed 30 minutes before general anesthesia.<br>* Other names: ESP;|
| Active Comparator: Control<br>In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively. | Other: Control<br>* Only general anesthesia will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption in the first 24 hours after surgery | Morphine consumption in the first 24 hours will be counted by IV PCA. Patients will be able to request opioids via PCA device when the vas score is 4 points or more when the arm is in the resting position. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative acute pain | Pain status will be evaluated based on VAS scores in two different positions: arm at rest and arm in abduction. Pain status will be evaluated at 1-3-6-12-24. hours after surgery. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be) | 1 day | 
| Remifentanil consumption during the surgery | Following induction of general anesthesia, anesthesia maintenance will be continued with sevoflurane to BIS 40-60 (bispectral index). When the BIS is between 40-60, remifentanil infusion rate will be changed considering ± 20% changes in blood pressure compared to baseline values.The total amount of remifentanil consumed will be recorded. | During the surgery | 
| The incidences of post-operative nausea and vomiting (PONV) | The patients will be evaluated according to the five-stage verbal descriptive PONV scale. If it is 3 points or more, ondansetron 4 mg IV will be administered. Wait for 8 hours for the next dose of ondansetron. (0 = None, 1 = Slight nausea, 2 = Moderate nausea, 3 = Once vomiting, 4 = vomiting more than one) | 1 day | 
| The number of patient required rescue analgesia | The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery | 1 day | 
| Post-operative chronic pain | Pain status will be evaluated in the third month after surgery based on VAS scores in two different positions: arm at rest and arm in abduction. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be) | 3. month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional Anesthesia, Acute and chronical pain, Pectoralis nerve block, Erector spine plane block