Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?

Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Patients in our study are divided in two groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.

Study Overview

• Status: Recruiting
• Conditions: Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration
• Intervention / Treatment: Other: PECS block; Other: local infiltration

Detailed Description

Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group. Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. Patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local aneshetic is administered in both groups after the induction of general anesthesia and before incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleftheria Soulioti, MD,PhD; Phone Number: 00306946745366; Email: eleftheriasoulioti@ymail.com
• Study Contact Backup: Name: Chrysanthi Batistaki, MD,PhD; Phone Number: 00302105832371; Email: chrysabatistaki@yahoo.gr

Study Locations

• Greece
  • Athens, Greece, 12462
    • Recruiting
    • 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• over 18 years of age
• ASA physical status I-III
• elective partial mastectomy

Exclusion Criteria:

• refusal of patient participation or inability to participate to the study

  • known allergic reaction to drugs included in the study design
  • contraindiations of performance of peripheral regional anesthesia
  • diabetes melitus or known neurological disorder
  • chronic pain disorders under therapy with opioids or other analgesic drugs for chronic pain
  • all male patients
  • all patients not speaking the Greek language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PECS block	Other: PECS block; PECS block is performed at the side of surgery (II) before incision with ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).
ACTIVE_COMPARATOR: local infiltration	Other: local infiltration; local infiltration of the surgical wound before incision with πwith ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intensity of acute postoperative pain	intensity of acute postoperative pain, numeric rating scale 0-10	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intensity of chronic pain	intensity of chronic pain with numeric rating scale 0-10	3 months
Prevalence of chronic neuropathic pain	Prevalence of chronic pain at the site of surgery, measured with the LANSS questionnaire	3 months
Prevalence of chronic neuropathic pain	Prevalence of chronic pain at the site of surgery, measured with YES./NO	3 months

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2020
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (ACTUAL): June 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 21, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: pain; mastectomy; PECS
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: BreastPecs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No