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

NCT05558917 | Unknown

• 1 other identifier: ASO.RianGen.22.02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Breast Neoplasms; Breast Carcinoma

Keywords

PECS2; ESP BLOCK; Breast Anesthesia; Mastectomy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying

  Postoperative 24 hours

• Morphine-equivalent consumption in the postoperative 24h in mastectomies 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

  Postoperative 24 hours

• PONV (Post Operating Nausea and Vomiting)

  Immediately after the surgery and at 2-4-8-12-24 hours after surgery

• Complications incidence

  Postoperative 24 hours

Study Arms (2)

PECS BLOCK 2

ACTIVE COMPARATOR

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

ESP BLOCK

EXPERIMENTAL

ESP block is a block that involves injection of local anesthetic below the elevator muscles of the spine.

Procedure: ESP BLOCK

Interventions

PECS BLOCK 2 PROCEDURE

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.

PECS BLOCK 2

ESP BLOCK PROCEDURE

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.

ESP BLOCK

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing mastectomy exclusively for breast cancer
• Presence of written informed consent to the trial

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, 15121, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mirco Leo, Physician

  Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 28, 2022
• Study Start: September 7, 2022
• Primary Completion: September 7, 2023
• Study Completion: November 7, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-08

Locations

IT (1)