NCT04443894

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

3.6 years

First QC Date

June 21, 2020

Last Update Submit

June 21, 2020

Conditions

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

Keywords

painmastectomyPECS

Outcome Measures

Primary Outcomes (1)

  • intensity of acute postoperative pain

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

    24 hours

Secondary Outcomes (3)

  • intensity of chronic pain

    3 months

  • Prevalence of chronic neuropathic pain

    3 months

  • Prevalence of chronic neuropathic pain

    3 months

Study Arms (2)

PECS block

ACTIVE COMPARATOR
Other: PECS block

local infiltration

ACTIVE COMPARATOR
Other: local infiltration

Interventions

PECS blockOTHER

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).

PECS block
local infiltrationOTHER

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).

local infiltration

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Eleftheria Soulioti, MD,PhD

CONTACT

00306946745366eleftheriasoulioti@ymail.com

Chrysanthi Batistaki, MD,PhD

CONTACT

00302105832371chrysabatistaki@yahoo.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
PATIENT OUTCOME ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anaesthesiology

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 23, 2020

Study Start

May 20, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 23, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)