Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery

Not Applicable

• Conditions: Breast Cancer; Breast Carcinoma; Breast Neoplasms
• Interventions: Procedure: ESP BLOCK; Procedure: PECS BLOCK 2

• Registration Number: NCT05558917
• Lead Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-09-07
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Study First Posted: 2022-09-28
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-09-07
• Study Completion: 2023-11-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP BLOCK	ESP BLOCK	ESP block is a block that involves injection of local anesthetic below the elevator muscles of the spine.
PECS BLOCK 2	PECS BLOCK 2	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.

Primary Outcome Measures

Name	Time	Method
Morphine equivalent consumption in the postoperative 24h in simple mastectomies	Postoperative 24 hours	Morphine-equivalent consumption in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in simple mastectomies.

Secondary Outcome Measures

Name	Time	Method
Complications incidence	Postoperative 24 hours	Number of times the patient experienced complications such as bleeding or pneumothorax
Length of hospitalization	Up to 7 days	Lenght in days
PONV (Post Operating Nausea and Vomiting)	Immediately after the surgery and at 2-4-8-12-24 hours after surgery	Number of times the patient experienced nausea or vomiting
Surgeon's Likert scale	Postoperative 24 hours	Surgeon satisfaction, from 1 - Strongly disagree to 5 - Strongly agree
Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying	Postoperative 24 hours	Morphine-equivalent consumption in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in mastectomies with axillary cavity emptying.
Time from end of surgery to first walk	Postoperative 72 hours	Time in hours
Patient's Likert Scale	Postoperative 24 hours	Patient satisfaction, from 1 - Strongly disagree to 5 - Strongly agree
Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying and implantation of prosthesis or expander	Postoperative 24 hours	Consumption of morphine equivalents in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in mastectomies with axillary cavity emptying and implantation of prosthesis or expander
Morphine-equivalent consumption in the postoperative 24h in mastectomies with prosthesis or expander placement	Postoperative 24 hours	Consumption of morphine equivalents in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in astecctomies with prosthesis or expander placement.

Trial Locations

Locations (1)

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Piedmont, Italy