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

Trial Title: Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery

NCT ID: NCT05558917

Condition: Breast Cancer
Breast Neoplasms
Breast Carcinoma

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
PECS2
ESP BLOCK
Breast Anesthesia
Mastectomy
Breast Cancer

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: PECS BLOCK 2
Description: 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.
Arm group label: PECS BLOCK 2

Intervention type: Procedure
Intervention name: ESP BLOCK
Description: 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.
Arm group label: ESP BLOCK

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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Address:
City: Alessandria
Zip: 15121
Country: Italy

Start date: September 7, 2022

Completion date: November 7, 2023

Lead sponsor:
Agency: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Agency class: Other

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05558917