Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy

Study Overview
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Brief Summary
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The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy.

Detailed Description
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Primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, ESP block and TPV block, in the post-operative pain-control after radical mastectomy. We will also evaluate both intra and post-operative opioid consumption, the incidence of PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.

Official Title
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Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.

Conditions
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Erector Spinae Plane Block, Breast Surgery, Thoracic Paravertebral Block, Post-operative Pain Control, Opioid Use

Intervention / Treatment
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* Procedure: Thoracic paravertebral block
* Procedure: Erector spinae plane Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 85 American Society of Anesthesiologists classification I - III Signature of consent to participate in the study Exclusion Criteria: Coagulopathies and / or use of antiplatelet / anticoagulant drugs Infections and/or lesions at the puncture site, BMI ≥40 allergies and / or contraindications to the administration of the drugs used in the study, use of chronic opioid therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPV Block<br>Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level. | Procedure: Thoracic paravertebral block<br>* Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level<br>|
| Experimental: ESP Block<br>Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level. | Procedure: Erector spinae plane Block<br>* Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain assessment | post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain) | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The number of days of hospitalization after surgery will be assessed | 3 days | 
| Evaluate the incidence and severity of persistent pain 6 months after surgery | Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain) | six months | 
| Opioid use | Intra and post-operative opioid use | 36 hours | 
| Incidence of PONV | Incidence of post operative nausea and vomiting (PONV) in the first 36 hours | 36 hours | 
| Assessment of patient satisfaction with the anesthesiological technique | Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates entirely dissatisfied and 5 indi- cates very satisfied | 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast surgery, Thoracic paravertebral block, Erector spinae plane block, Mastectomy, post-operative pain control