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Clinical Trials/EUCTR2021-005886-41-DK
EUCTR2021-005886-41-DK
Active, Not Recruiting
Phase 1

Efficacy of Perioperative Long-acting Anesthesia by Local Infiltration Following Median Sternotomy - The PAIN Trial - The PAIN Trial

Aarhus University Hospital0 sites100 target enrollmentJanuary 24, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acute postoperative pain after coronary bypass grafting surgery.
Sponsor
Aarhus University Hospital
Enrollment
100
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 24, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing first\-time, non\-emergent coronary artery bypass grafting including harvest of the left internal mammary artery through a median sternotomy
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 40
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 60

Exclusion Criteria

  • Emergent treatment (\<24 hours)
  • Prior sternotomy or cardiac surgery
  • Concurrent heart surgery other than arrythmia surgery (i.e lung vein ablation and/or left appendage closure)
  • Daily use of opioids within the last 6 month prior to enrollment
  • Preoperative regular use of corticosteroids
  • Known allergy or intolerance to any of the included drugs
  • Woman of childbearing age without negative pregnancy test and nursing women
  • Any known condition that might interfere with the used drugs
  • Known impaired kidney function (defined as eGFR \< 30 ml/min)
  • Active participation in another interventional trial with potential impact on postoperative pain and/or respiratory function

Outcomes

Primary Outcomes

Not specified

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