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

• ClinicalTrials.gov Identifier: NCT05558917
• Recruitment Status: Enrolling by invitation
• First Posted: September 28, 2022
• Last Update Posted: September 28, 2022
• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Information provided by (Responsible Party): Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Tracking Information

• First Submitted Date: September 7, 2022
• First Posted Date: September 28, 2022
• Last Update Posted Date: September 28, 2022
• Actual Study Start Date: September 7, 2022
• Estimated Primary Completion Date: September 7, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2022)

Morphine equivalent consumption in the postoperative 24h in simple mastectomies [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 26, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Breast Cancer
• Breast Neoplasms
• Breast Carcinoma

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.
• 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.

Study Arms

• 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.
  Intervention: Procedure: PECS BLOCK 2
• Experimental: ESP BLOCK
  ESP block is a block that involves injection of local anesthetic below the elevator muscles of the spine.
  Intervention: Procedure: ESP BLOCK

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: September 26, 2022): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 7, 2023
• Estimated Primary Completion Date: September 7, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT05558917
• Other Study ID Numbers: ASO.RianGen.22.02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Original Responsible Party: Same as current
• Current Study Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mirco Leo, Physician; Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

• PRS Account: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Verification Date: August 2022