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.

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Emilia Romagna
    • Cesena, Emilia Romagna, Italy, 47521
      • Domenico Pietro Santonastaso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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
Experimental: ESP Block; 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; Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	The number of days of hospitalization after surgery will be assessed	3 days
Evaluate the incidence and severity of persistent pain 6 months after surgery	Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain)	six months
Opioid use	Intra and post-operative opioid use	36 hours
Incidence of PONV	Incidence of post operative nausea and vomiting (PONV) in the first 36 hours	36 hours
Assessment of patient satisfaction with the anesthesiological technique	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"	36 hours

Collaborators and Investigators

• Sponsor: AUSL Romagna Rimini
• Investigators: Principal Investigator: Domenico P Santonastaso, MD, AUSL Romagna, M. Bufalini Hospital, Cesena

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Thoracic paravertebral block; Mastectomy; Erector spinae plane block; breast surgery; post-operative pain control
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ELETTRA; 2613 (Registry Identifier: Reg. sperimentazioni)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No