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Clinical Trials/NCT03448913
NCT03448913
Completed
Not Applicable

Prospective Observational Single-centre Study: Difference in the Incidence of Chronic Pain After Breast Surgery Between General Anesthesia and General Anesthesia Associated With PECS Block (Block REducing Pain After Surgery Trial)

University of Padova1 site in 1 country140 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain Post-Procedural
Sponsor
University of Padova
Enrollment
140
Locations
1
Primary Endpoint
Chronic pain at six months
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This observational study evaluates difference in chronic pain after six months from surgery between patients who received PECS block and general anesthesia versus general anesthesia alone.

Detailed Description

PECS block is used as a pain relief technique during breast surgery. However at the actual state of knowledge there is no strong evidence that its use could lower incidence of chronic pain compared to general anesthesia alone. Moreover for its use an adequate skill with ultrasound machine is required. For this reason only some anesthesiologists in our reality use this technique it in clinical practice.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
March 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Padova
Responsible Party
Principal Investigator
Principal Investigator

Alessandro De Cassai

Medical Doctor

University of Padova

Eligibility Criteria

Inclusion Criteria

  • programmed breast surgery
  • informed consent

Exclusion Criteria

  • bilateral breast surgery

Outcomes

Primary Outcomes

Chronic pain at six months

Time Frame: six months

Presence of chronic pain at six months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain

Secondary Outcomes

  • Chronic pain at nine months(nine months)
  • Chronic pain at twelve months(twelve months)
  • Difference in pain in the first 24 hours after surgery(first 24 hours after surgery)
  • Chronic pain at three months(three months)
  • Difference in opioid consumption during surgery(day of surgery)

Study Sites (1)

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