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

Breast Cancer Clinical Trial

— ESPECS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05558917
• Other study ID #: ASO.RianGen.22.02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: November 7, 2023

Study information

• Verified date: August 2022
• Source: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: November 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo	Alessandria	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications incidence	Number of times the patient experienced complications such as bleeding or pneumothorax	Postoperative 24 hours
Secondary	Time from end of surgery to first walk	Time in hours	Postoperative 72 hours
Secondary	Length of hospitalization	Lenght in days	Up to 7 days
Secondary	Patient's Likert Scale	Patient satisfaction, from 1 - Strongly disagree to 5 - Strongly agree	Postoperative 24 hours
Secondary	Surgeon's Likert scale	Surgeon satisfaction, from 1 - Strongly disagree to 5 - Strongly agree	Postoperative 24 hours