Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery (ESPECS)

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Status: Invitation-only

Conditions: Breast Cancer; Breast Neoplasms; Breast Carcinoma

Treatments: Procedure: ESP BLOCK; Procedure: PECS BLOCK 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05558917

ASO.RianGen.22.02

Details and patient eligibility

About

The study aims to compare the efficacy of the two operating blocks PECS2 and ESP by measuring postoperative opioid consumption and, secondarily, to compare (between PECS and ESP) postoperative opioid consumption between surgery with/without axillary cavity dissection and with/without implantation of prosthesis or expansion

Full description

Breast cancer is the most frequent type of cancer in the female population. Early detection is the most effective tool for improving prognosis, and the surgical approach plays a central role in the treatment of this disease. However, many are the psychophysical implications that patients face: among the main ones is postoperative and chronic pain, a symptom that greatly worsens the quality of life.

In the last decade it has been witnessed an important development of locoregional anesthesia techniques in all surgeries. In breast surgery, particularly mastectomy, the following locoregional anesthesia techniques are referred to as the Gold Standard:

1. PVB (Paravertebral Block)
2. PECS2 BLOCK (or modified PECS). For the same purposes, ESP Block (Erector Spinae Plane Block) has been applied experimentally, which has already shown its effectiveness in breast surgery in several trials.

By comparing postoperative opioid consumption between the two groups of patients, divided into PECS Block and ESP Block, the study aims to identify which anesthesia block is most effective in order to improve the care of patients undergoing mastectomy.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing mastectomy exclusively for breast cancer
• Presence of written informed consent to the trial

Exclusion criteria

• Bilateral breast surgery
• Previous drug use
• Chronic opioid and minor opioid therapy
• BMI >40
• Allergy or contraindications to taking Paracetamol and Toradol
• Inability to use PCA (Patient Controlled Analgesia)
• Intraoperative opioid administration
• Patients with neuropathy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

PECS BLOCK 2

Active Comparator group

Description:

PECS 2 (or modified PECS) is a block that involves the administration of local anesthetic under ultrasound guidance between the great pectoral and small pectoral and between the small pectoral and serratus anterior.

Treatment:

Procedure: PECS BLOCK 2

ESP BLOCK

Experimental group

Description:

ESP block is a block that involves injection of local anesthetic below the elevator muscles of the spine.

Treatment:

Procedure: ESP BLOCK