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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04457115
Other study ID # ELETTRA
Secondary ID 2613
Status Completed
Phase N/A
First received
Last updated
Start date April 27, 2020
Est. completion date November 15, 2021

Study information

Verified date November 2021
Source AUSL Romagna Rimini
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date November 15, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Italy Domenico Pietro Santonastaso Cesena Emilia Romagna

Sponsors (1)

Lead Sponsor Collaborator
AUSL Romagna Rimini

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative pain assessment post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain) 12 hours
Secondary Length of hospital stay The number of days of hospitalization after surgery will be assessed 3 days
Secondary 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
Secondary Opioid use Intra and post-operative opioid use 36 hours
Secondary Incidence of PONV Incidence of post operative nausea and vomiting (PONV) in the first 36 hours 36 hours
Secondary 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
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