Onset of Sensory Block After Thoracic ESP Block
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOspedale Santa Maria Goretti
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
ASA score I-II-III.
Schedule of breast surgery
Schedule of ESPB
Disqualifiers
Allergy to local anaesthetics
Cardiopathies, nephropathies, hepatopathies, central or peripheral neuropathies uncompensated
Infection at the injection site
Uncooperative patient
Trial population
Patients undergoing ESP block for simple quadrantectomy and partial resection with or without lymphnode resection
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
ESP block
Procedure/SurgeryThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
One minute after ESPB is performed2
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.
Time frame
3 minutes after ESPB is performed3
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.
Time frame
5 minutes after ESPB is performed4
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.
Time frame
10 minutes after ESPB is performedSponsors and contacts
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Source ClinicalTrials.gov