NCT04457115

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

June 22, 2020

Last Update Submit

November 15, 2021

Conditions

Breast SurgeryThoracic Paravertebral BlockPost-operative Pain ControlErector Spinae Plane BlockOpioid Use

Keywords

breast surgeryThoracic paravertebral blockErector spinae plane blockMastectomypost-operative pain control

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain assessment

    post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)

    12 hours

Secondary Outcomes (5)

  • Length of hospital stay

    3 days

  • Evaluate the incidence and severity of persistent pain 6 months after surgery

    six months

  • Opioid use

    36 hours

  • Incidence of PONV

    36 hours

  • Assessment of patient satisfaction with the anesthesiological technique

    36 hours

Study Arms (2)

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.

Procedure: Thoracic paravertebral block

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.

Procedure: Erector spinae plane Block

Interventions

Thoracic paravertebral blockPROCEDURE

Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level

TPV Block
Erector spinae plane BlockPROCEDURE

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

ESP Block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 85
  • American Society of Anesthesiologists classification I - III
  • Signature of consent to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Domenico Pietro Santonastaso

Cesena, Emilia-Romagna, 47521, Italy

Location

Related Publications (1)

  • 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.

    PMID: 37328817DERIVED

Study Officials

  • Domenico P Santonastaso, MD

    AUSL Romagna, M. Bufalini Hospital, Cesena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 7, 2020

Study Start

April 27, 2020

Primary Completion

September 30, 2021

Study Completion

November 15, 2021

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)