RecruitingNCT06642142

Onset of Sensory Block After Thoracic ESP Block

Evaluation of the Onset and the Extent of Sensory Block After Thoracic ESP Block in Breast Surgery - a Prospective Observational Study


Sponsor

Ospedale Santa Maria Goretti

Enrollment

30 participants

Start Date

Nov 7, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to to evaluate the changes in cold sensitivity and the onset of sensory block after performing a thoracic ESP block. It reflects the time it takes for the local anaesthetic to spread into the paravertebral space leading to changes in cold sensitivity in the chest. The study population are patients undergoing simple quadrantectomy or partial resection with or without sentinel lymphnode removal, in the operating rooms of Santa Maria Goretti Hospital in Latina. This study is observational because it simply describes and records the effects of a procedure (the ESP block) on treated patients during a period of observation. Before surgery, unilateral thoracic ESP block (T4 level) with a sterile, ultrasound-guided technique will be performed. A timer will be started to mark the time for subsequent evaluations. At 1,3,5 and after every 5 minutes following the block up to 40 minutes or until induction of general anaesthesia, the cold sensitivity of the chest will be explored.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is measuring how quickly the numbing effect of a nerve block (erector spinae plane block, or ESPB) sets in when used for pain control before breast surgery. **You may be eligible if...** - You are 18 years or older - You are scheduled to undergo breast surgery - You are scheduled to receive an ESPB nerve block as part of your anesthesia plan - Your overall health is acceptable for surgery (ASA score I, II, or III) **You may NOT be eligible if...** - You are allergic to local anesthetic medicines - You have significant uncontrolled heart, kidney, liver, or nerve problems - You have an infection at the injection site - You are unable to cooperate with the study procedures - Your BMI is below 20 or above 40 - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREESP block

The ESPB will be performed at the T4 level, monolaterally (according to the surgical side), with 30ml volume of 0.5% Ropivacaine injected with a 20-gauge, 50-mm-long needle. The technique used is the standard ultrasound-guided, sterile procedure. Soon after performing the block, a timer will be started to mark the time for subsequent evaluations. At 1,3,5 and after every 5 minutes following the block until 40 minutes or until general anaesthesia is induced, the cold sensitivity of the chest will be explored.


Locations(1)

Ospedale Santa Maria Goretti, Via Lucia Scaravelli

Latina, Italy, Italy

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NCT06642142


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