Onset of Sensory Block After Thoracic ESP Block

NCT06642142 | Recruiting

• 1 other identifier: 2024-07-OSSSZ-6435-LUPELLI
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Surgery; ESPB

Keywords

ESPB

Outcome Measures

Primary Outcomes (10)

• The onset of sensory block after thoracic ESP block after one minute

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  One minute after ESPB is performed

• The onset of sensory block after thoracic ESP block after three minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  3 minutes after ESPB is performed

• The onset of sensory block after thoracic ESP block after five minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  5 minutes after ESPB is performed

• The onset of sensory block after thoracic ESP block after 10 minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  10 minutes after ESPB is performed

• The onset of sensory block after thoracic ESP block after 15 minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  15 minutes after ESPB is performed

• The onset of sensory block after thoracic ESP block after 20 minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  20 minutes after ESPB is performed

• The onset of sensory block after thoracic ESP block after 25 minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  25 minutes after ESPB is performed

• The onset of sensory block after thoracic ESP block after 30 minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  30 minutes after ESPB is performed

• The onset of sensory block after thoracic ESP block after 35 minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  35 minutes after ESPB is performed

• The onset of sensory block after thoracic ESP block after 40 minutes

  Assessment of the onset, the extent and the evolution, as the time passes by, of sensory changes, described through absent or altered cold sensitivity on the thoracic dermatomeres, after performing thoracic (T4 level) ESPB.

  40 minutes after ESPB is performed

Interventions

ESP block PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ESP block for simple quadrantectomy and partial resection with or without lymphnode resection

You may qualify if:

• Age ≥ 18 years.
• ASA score I-II-III.
• Schedule of breast surgery
• Schedule of ESPB
• Consent to the study

You may not qualify if:

• Allergy to local anaesthetics
• Cardiopathies, nephropathies, hepatopathies, central or peripheral neuropathies uncompensated
• Infection at the injection site
• Uncooperative patient
• BMI \< 20, \> 40
• Difficulty in visualising target structures or the LA spread (failure of technique)
• Pregnancy status

Sponsors & Collaborators

• Ospedale Santa Maria Goretti: lead

Study Sites (1)

Ospedale Santa Maria Goretti, Via Lucia Scaravelli

Latina, Italy, 04100, Italy

RECRUITING

Central Study Contacts

Irene Lupelli, MD

CONTACT

+39 3497772231; irene.lupelli@gmail.com

Alessandro De Cassai, MD

CONTACT

+39 3204169392; alessandro.decassai@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: November 7, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

IT (1)