An interventional study of Thoracic paravertebral block and Erector spinae plane Block in Breast Surgery, Thoracic Paravertebral Block and Post-operative Pain Control, sponsored by AUSL Romagna Rimini. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by AUSL Romagna Rimini · Not applicable, Interventional, and Treatment
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.
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 78 is close to the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →AUSL Romagna Rimini is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level.
Procedure: Thoracic paravertebral block
Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level.
Procedure: Erector spinae plane 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 performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level
Post-operative pain assessment
post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)
Time frame: 12 hours
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
Plan to share: No
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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AUSL Romagna Rimini