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

AUSL Romagna Rimini78 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Thoracic paravertebral blockPROCEDURE

Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level

Erector spinae plane BlockPROCEDURE

Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Domenico Pietro Santonastaso

Cesena, Emilia-Romagna, Italy

Outcomes

Primary Outcomes

Post-operative pain assessment

post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)

Time frame: 12 hours

Secondary Outcomes

Length of hospital stay

The number of days of hospitalization after surgery will be assessed

Time frame: 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)

Time frame: six months

Opioid use

Intra and post-operative opioid use

Time frame: 36 hours

Incidence of PONV

Incidence of post operative nausea and vomiting (PONV) in the first 36 hours

Time frame: 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"

Time frame: 36 hours

Data from ClinicalTrials.gov

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