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Completed

NCT Number: NCT04457115

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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Domenico Pietro Santonastaso

Cesena, Emilia-Romagna, 47521, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Post-operative pain assessment

    Time frame: 12 hours

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

Secondary outcomes

  1. Length of hospital stay

    Time frame: 3 days

    The number of days of hospitalization after surgery will be assessed

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

    Time frame: six months

    Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain)

  3. Opioid use

    Time frame: 36 hours

    Intra and post-operative opioid use

  4. Incidence of PONV

    Time frame: 36 hours

    Incidence of post operative nausea and vomiting (PONV) in the first 36 hours

  5. Assessment of patient satisfaction with the anesthesiological technique

    Time frame: 36 hours

    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"

Sponsors and collaborators

Lead sponsor

AUSL Romagna Rimini

Other

Registry information

Official study title

Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2020
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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