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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05558917
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2022
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Tracking Information
First Submitted Date  ICMJE September 7, 2022
First Posted Date  ICMJE September 28, 2022
Last Update Posted Date September 28, 2022
Actual Study Start Date  ICMJE September 7, 2022
Estimated Primary Completion Date September 7, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Breast Neoplasms
  • Breast Carcinoma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 26, 2022)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 7, 2023
Estimated Primary Completion Date September 7, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05558917
Other Study ID Numbers  ICMJE 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  ICMJE 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  ICMJE Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP