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

Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery: Randomized Controlled Trial on Postoperatory Oppioid Consumption

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer; Breast Neoplasms; Breast Carcinoma
• Intervention / Treatment: Procedure: PECS BLOCK 2; Procedure: ESP BLOCK

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: PECS BLOCK 2; With the patient supine, the linear probe will be placed in the sagittal plane slightly lateral to the hemiclavicular line ipsilateral to the surgical site. Once both muscle planes of interest have been identified, in-plane needle insertion will proceed in the cranio-caudal direction. The first local anesthetic administration with Ropivacaine 0.5% will be 20ml between small pectoralis and serratus anterior. Coming out with the needle, 10ml of Ropivacaine 0.5% will then be injected between large and small pectoral.
Experimental: ESP BLOCK; ESP block is a block that involves injection of local anesthetic below the elevator muscles of the spine.	Procedure: ESP BLOCK; Positioning yourself behind the patient, lying on her side with the surgical hemilateral on top, you place the linear ultrasound probe in the sagittal plane and find the lateral margin of the transverse process. At this point, the blocking needle is inserted in the caudocranial direction and 25ml of Ropivacaine 0.5% is injected, taking care to visualize the anesthetic spread in the cranial direction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine equivalent consumption in the postoperative 24h in simple mastectomies	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.	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying	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.	Postoperative 24 hours
Morphine-equivalent consumption in the postoperative 24h in mastectomies with prosthesis or expander placement	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.	Postoperative 24 hours
Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying and implantation of prosthesis or expander	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	Postoperative 24 hours
PONV (Post Operating Nausea and Vomiting)	Number of times the patient experienced nausea or vomiting	Immediately after the surgery and at 2-4-8-12-24 hours after surgery
Complications incidence	Number of times the patient experienced complications such as bleeding or pneumothorax	Postoperative 24 hours
Time from end of surgery to first walk	Time in hours	Postoperative 72 hours
Length of hospitalization	Lenght in days	Up to 7 days
Patient's Likert Scale	Patient satisfaction, from 1 - Strongly disagree to 5 - Strongly agree	Postoperative 24 hours
Surgeon's Likert scale	Surgeon satisfaction, from 1 - Strongly disagree to 5 - Strongly agree	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Investigators: Principal Investigator: Mirco Leo, Physician, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Anticipated): September 7, 2023
• Study Completion (Anticipated): November 7, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Mastectomy; PECS2; ESP BLOCK; Breast Anesthesia
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ASO.RianGen.22.02

Drug and device information, study documents

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