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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04457115

Enrollment

Registered

2020-07-07

Start date

2020-04-27

Completion date

2021-11-15

Last updated

2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

PROCEDUREThoracic paravertebral block

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

PROCEDUREErector spinae plane Block

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Post-operative pain assessment	12 hours	post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)

Secondary

Measure	Time frame	Description
Length of hospital stay	3 days	The number of days of hospitalization after surgery will be assessed
Evaluate the incidence and severity of persistent pain 6 months after surgery	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)
Opioid use	36 hours	Intra and post-operative opioid use
Incidence of PONV	36 hours	Incidence of post operative nausea and vomiting (PONV) in the first 36 hours
Assessment of patient satisfaction with the anesthesiological technique	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026