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

Primary Purpose

Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
PECS block
local infiltration
Sponsored by
Attikon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration focused on measuring pain, mastectomy, PECS

Eligibility Criteria

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

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PECS block

local infiltration

Arm Description

Outcomes

Primary Outcome Measures

intensity of acute postoperative pain
intensity of acute postoperative pain, numeric rating scale 0-10

Secondary Outcome Measures

intensity of chronic pain
intensity of chronic pain with numeric rating scale 0-10
Prevalence of chronic neuropathic pain
Prevalence of chronic pain at the site of surgery, measured with the LANSS questionnaire
Prevalence of chronic neuropathic pain
Prevalence of chronic pain at the site of surgery, measured with YES./NO

Full Information

First Posted
June 21, 2020
Last Updated
June 21, 2020
Sponsor
Attikon Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04443894
Brief Title
Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
Official Title
Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration
Keywords
pain, mastectomy, PECS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
PATIENT OUTCOME ASSESSOR
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PECS block
Arm Type
Active Comparator
Arm Title
local infiltration
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
PECS block
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
local infiltration
Intervention Description
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).
Primary Outcome Measure Information:
Title
intensity of acute postoperative pain
Description
intensity of acute postoperative pain, numeric rating scale 0-10
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
intensity of chronic pain
Description
intensity of chronic pain with numeric rating scale 0-10
Time Frame
3 months
Title
Prevalence of chronic neuropathic pain
Description
Prevalence of chronic pain at the site of surgery, measured with the LANSS questionnaire
Time Frame
3 months
Title
Prevalence of chronic neuropathic pain
Description
Prevalence of chronic pain at the site of surgery, measured with YES./NO
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleftheria Soulioti, MD,PhD
Phone
00306946745366
Email
eleftheriasoulioti@ymail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chrysanthi Batistaki, MD,PhD
Phone
00302105832371
Email
chrysabatistaki@yahoo.gr
Facility Information:
Facility Name
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrysanthi Batistaki, MD, PhD
Phone
0030 210 5832371
Email
chrysabatistaki@yahoo.gr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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