Clinical trial NCT05558917: Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
Official title: Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery: Randomized Controlled Trial on Postoperatory Oppioid Consumption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Breast Carcinoma
Keywords: PECS2
ESP BLOCK
Breast Anesthesia
Mastectomy
Breast Cancer
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Morphine equivalent consumption in the postoperative 24h in simple mastectomies
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying
timeFrame: Postoperative 24 hours
measure: Morphine-equivalent consumption in the postoperative 24h in mastectomies with prosthesis or expander placement
timeFrame: Postoperative 24 hours
measure: Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying and implantation of prosthesis or expander
timeFrame: Postoperative 24 hours
measure: PONV (Post Operating Nausea and Vomiting)
timeFrame: Immediately after the surgery and at 2-4-8-12-24 hours after surgery
measure: Complications incidence
timeFrame: Postoperative 24 hours
measure: Time from end of surgery to first walk
timeFrame: Postoperative 72 hours
measure: Length of hospitalization
timeFrame: Up to 7 days
measure: Patient's Likert Scale
timeFrame: Postoperative 24 hours
measure: Surgeon's Likert scale
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
state: Piedmont
Study officials:
affiliation: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
name: Mirco Leo, Physician
role: PRINCIPAL_INVESTIGATOR
References: