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

Opioid Use Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457115
• Other study ID #: ELETTRA
• Secondary ID: 2613
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: AUSL Romagna Rimini
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 15, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Domenico Pietro Santonastaso	Cesena	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
AUSL Romagna Rimini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain assessment	post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)	12 hours
Secondary	Length of hospital stay	The number of days of hospitalization after surgery will be assessed	3 days
Secondary	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
Secondary	Opioid use	Intra and post-operative opioid use	36 hours
Secondary	Incidence of PONV	Incidence of post operative nausea and vomiting (PONV) in the first 36 hours	36 hours
Secondary	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