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

Not Applicable

Completed

• Conditions: Erector Spinae Plane Block; Breast Surgery; Post-operative Pain Control; Thoracic Paravertebral Block; Opioid Use
• Interventions: Procedure: Erector spinae plane Block; Procedure: Thoracic paravertebral block

• Registration Number: NCT04457115
• Lead Sponsor: AUSL Romagna Rimini

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.

Study Timeline

• Study Start: 2020-04-27
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Primary Completion: 2021-09-30
• Status Verified: 2021-11
• Study Completion: 2021-11-15
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP Block	Erector spinae plane Block	Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level.
TPV Block	Thoracic paravertebral block	Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of PONV	36 hours	Incidence of post operative nausea and vomiting (PONV) in the first 36 hours
Opioid use	36 hours	Intra and post-operative opioid use
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"
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)

Trial Locations

Locations (1)

Domenico Pietro Santonastaso; 🇮🇹 Cesena, Emilia Romagna, Italy