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Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy

NCT ID: NCT04457115

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2021-11-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Surgery Thoracic Paravertebral Block Post-operative Pain Control Erector Spinae Plane Block Opioid Use

Keywords

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breast surgery Thoracic paravertebral block Erector spinae plane block Mastectomy post-operative pain control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TPV Block

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

Group Type EXPERIMENTAL

Thoracic paravertebral block

Intervention Type PROCEDURE

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

ESP Block

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

Group Type EXPERIMENTAL

Erector spinae plane Block

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AUSL Romagna Rimini

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Domenico P Santonastaso, MD

Role: PRINCIPAL_INVESTIGATOR

AUSL Romagna, M. Bufalini Hospital, Cesena

Locations

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Domenico Pietro Santonastaso

Cesena, Emilia-Romagna, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 37328817 (View on PubMed)

Other Identifiers

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2613

Identifier Type: REGISTRY

Identifier Source: secondary_id

ELETTRA

Identifier Type: -

Identifier Source: org_study_id