search
Back to results

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

Primary Purpose

Breast Cancer, Breast Neoplasms, Breast Carcinoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PECS BLOCK 2
ESP BLOCK
Sponsored by
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring PECS2, ESP BLOCK, Breast Anesthesia, Mastectomy, Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PECS BLOCK 2

ESP BLOCK

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
PONV (Post Operating Nausea and Vomiting)
Number of times the patient experienced nausea or vomiting
Complications incidence
Number of times the patient experienced complications such as bleeding or pneumothorax
Time from end of surgery to first walk
Time in hours
Length of hospitalization
Lenght in days
Patient's Likert Scale
Patient satisfaction, from 1 - Strongly disagree to 5 - Strongly agree
Surgeon's Likert scale
Surgeon satisfaction, from 1 - Strongly disagree to 5 - Strongly agree

Full Information

First Posted
September 7, 2022
Last Updated
September 26, 2022
Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
search

1. Study Identification

Unique Protocol Identification Number
NCT05558917
Brief Title
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
Acronym
ESPECS
Official Title
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery: Randomized Controlled Trial on Postoperatory Oppioid Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
September 7, 2023 (Anticipated)
Study Completion Date
November 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: PVB (Paravertebral Block) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, Breast Carcinoma
Keywords
PECS2, ESP BLOCK, Breast Anesthesia, Mastectomy, Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PECS BLOCK 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ESP BLOCK
Arm Type
Experimental
Arm Description
ESP block is a block that involves injection of local anesthetic below the elevator muscles of the spine.
Intervention Type
Procedure
Intervention Name(s)
PECS BLOCK 2
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
ESP BLOCK
Intervention 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.
Primary Outcome Measure Information:
Title
Morphine equivalent consumption in the postoperative 24h in simple mastectomies
Description
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.
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying
Description
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.
Time Frame
Postoperative 24 hours
Title
Morphine-equivalent consumption in the postoperative 24h in mastectomies with prosthesis or expander placement
Description
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.
Time Frame
Postoperative 24 hours
Title
Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying and implantation of prosthesis or expander
Description
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
Time Frame
Postoperative 24 hours
Title
PONV (Post Operating Nausea and Vomiting)
Description
Number of times the patient experienced nausea or vomiting
Time Frame
Immediately after the surgery and at 2-4-8-12-24 hours after surgery
Title
Complications incidence
Description
Number of times the patient experienced complications such as bleeding or pneumothorax
Time Frame
Postoperative 24 hours
Title
Time from end of surgery to first walk
Description
Time in hours
Time Frame
Postoperative 72 hours
Title
Length of hospitalization
Description
Lenght in days
Time Frame
Up to 7 days
Title
Patient's Likert Scale
Description
Patient satisfaction, from 1 - Strongly disagree to 5 - Strongly agree
Time Frame
Postoperative 24 hours
Title
Surgeon's Likert scale
Description
Surgeon satisfaction, from 1 - Strongly disagree to 5 - Strongly agree
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirco Leo, Physician
Organizational Affiliation
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
City
Alessandria
State/Province
Piedmont
ZIP/Postal Code
15121
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs