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

AUSL Romagna Rimini

Status: Completed

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

Treatments: Procedure: Erector spinae plane Block; Procedure: Thoracic paravertebral block

Study type: Interventional

Funder types: Other

Identifiers

NCT04457115

2613

ELETTRA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

78 participants in 2 patient groups

TPV Block

Experimental group

Description:

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

Treatment:

Procedure: Thoracic paravertebral block

ESP Block

Experimental group

Description:

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

Treatment:

Procedure: Erector spinae plane Block