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| ID | Type | Description | Link |
|---|---|---|---|
| 2613 | Registry Identifier | Reg. sperimentazioni |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPV Block | Experimental | Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level. |
|
| ESP Block | Experimental | Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic paravertebral block | Procedure | Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain assessment | post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain) | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | The number of days of hospitalization after surgery will be assessed | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Domenico P Santonastaso, MD | AUSL Romagna, M. Bufalini Hospital, Cesena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Domenico Pietro Santonastaso | Cesena | Emilia-Romagna | 47521 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37328817 | Derived | Santonastaso DP, de Chiara A, Righetti R, Marandola D, Sica A, Bagaphou CT, Rosato C, Tognu A, Curcio A, Lucchi L, Russo E, Agnoletti V. Efficacy of bi-level erector spinae plane block versus bi-level thoracic paravertebral block for postoperative analgesia in modified radical mastectomy: a prospective randomized comparative study. BMC Anesthesiol. 2023 Jun 16;23(1):209. doi: 10.1186/s12871-023-02157-2. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 21, 2022 | |
| Reset | Sep 1, 2023 |
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| Erector spinae plane Block | Procedure | Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level |
|
| six months |
| Opioid use | Intra and post-operative opioid use | 36 hours |
| Incidence of PONV | Incidence of post operative nausea and vomiting (PONV) in the first 36 hours | 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" | 36 hours |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 21, 2022 | Sep 1, 2023 |